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local medical safety specialist

Johnson & Johnson

<div><p>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com</p><p><b>
Job Function:
</b></p>Product Safety<p><b>
Job Sub Function:
</b></p>Pharmacovigilance<p><b>
Job Category:</b></p>
Scientific/Technology<p><b>
All Job Posting Locations:</b></p>
Istanbul, Turkey<p><b>
Job Description:</b></p><p><b>
About Innovative Medicine</b></p><p>
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.</p><p>
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</p><p>
Learn more at https://www.jnj.com/innovative-medicine</p><p>
We are searching for the best talent for a Medical Safety Specialist. This position will be located in Istanbul, Turkey.</p><h3 class="jobSectionHeader"><b>
Essential Job Duties and Responsibilities</b></h3><p>
The position is responsible for supporting the compliance of LOC Safety activities of TURGAN cluster by mainly focused on Turkiye, covering medicinal products, with local regulations, company policies, and global standards, including any Product vigilance agreements with third-party partners.</p><p>
It involves assisting in establishing and maintaining effective Pharmacovigilance and Risk management systems and supporting the oversight of the products within its responsibility.</p><p>
The role includes contributing to the proactive management of Benefit Risk Management throughout the product life cycle, tailoring actions to local needs. Additionally, it involves aiding in safety reporting requirements as needed by Marketing Authorization Holders (MAH) and study sponsors, as applicable.</p><h3 class="jobSectionHeader"><b>
Safety Management &amp; Reporting</b></h3><p>
Oversight and Providing Input</p><ul><li>
Support Data-generating Activities: Assist in overseeing data-generating activities to ensure appropriate review and reporting processes are included in project documents for reporting potential Adverse Events (AEs), such as patient support programs, market research surveys, and internet sites, as applicable. Provide support to the Hub for Related Research Activities (RRA) activities, where applicable.</li><li>
Vendor Contracts: Ensure, in collaboration with the Hub if applicable, that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.</li><li>
Product Portfolio Oversight: Support the oversight of the full product portfolio and establish links with local management and key stakeholders. Assist in overseeing the safety aspects of clinical studies conducted in the territory, as applicable.</li></ul><p>
Submission to Regulatory Authority</p><ul><li>
Support the coordination of safety requirements delegated by Marketing Authorization Holders (MAH).</li><li>
Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners independently and with minimal supervision</li><li>
Independently and with minimal supervision, ensure timely submission of aggregate safety reports (e.g. DSUR, PBRERs etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).</li><li>
Independently and with minimal supervision, ensure timely submission of other safety reports (e.g. DHPC, RMP etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).</li></ul><p>
Signal Detection</p><ul><li>
Assist in implementing a robust local signal detection process if required and ensure the reporting of potential single case signals or clusters of similar events identified during case processing, as applicable.</li></ul><p>
Aggregate Reporting</p><ul><li>
Assist in local review and ensure the submission of Periodic Benefit Risk Evaluaiton Reports (PBRERs), providing due dates to Global Medical Safety (GMS), and promoting synchronization with the Global PSUR schedule, in accordance with national requirements and in collaboration with the local Regulatory Affairs unit.</li><li>
Products for Local Opportunity (POLOs): When Global Medical Safety (GMS) does not provide the Aggregate Reports, support the preparation of specific reports (e.g., PBRERs) if not already provided by a third party under a PV agreement, as applicable.</li></ul><p>
Business Continuity</p><ul><li>
Local Business Continuity Plans: Assist in the development and implementation of local business continuity plans (e.g., inspection readiness, Adverse Event reporting coverage) in collaboration with the case management team.</li><li>
24-hour Coverage: Support the establishment of an effective system for 24-hour coverage.</li><li>
Day-to-day Pharmacovigilance (PV) Functions: Support to ensure the satisfactory performance of day-to-day Pharmacovigilance (PV) functions and maintain optimal regulatory compliance at the Local Operating Company (LOC) level in collaboration with the case management team.</li></ul><p>
Risk Management</p><ul><li>
Implementation of Risk Management Plans: Support the implementation of Risk Management Plans and Urgent Safety Restrictions, if required.</li></ul><p>
New Safety Information</p><ul><li>
Dissemination of New Safety Information: Assist in taking appropriate measures to ensure that new safety information is available to RA and Health Care Professionals (HCP) in a timely manner, i.e., DHPC, CCDS implementation into local label, USR in collaboration with adequate partners if applicable.</li></ul><h3 class="jobSectionHeader"><b>
Benefit Risk Management</b></h3><ul><li>
Establish product knowledge: Assist in establishing product knowledge with a focus on safety profiles, therapeutic area, and disease pathway knowledge to support the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety Leader or MSO.</li><li>
Act as a safety expert: Support safety expert activities in cross-functional team meetings and conduct training on safety-relevant aspects, as appropriate.</li><li>
Risk Management Plan status updates: Assist in providing Risk Management Plan status updates.</li><li>
Local RMPs/Addendums: Support the preparation of Local RMPs/Addendums, etc. (if performed by LMS)</li><li>
Implementation of Risk Management Plans: Participate in the implementation of Risk Management Plans and Urgent Safety Restrictions, if required.</li><li>
Benefit-risk and product safety meetings: Participate in meetings with relevant partners to discuss and evaluate topics related to benefit-risk and product safety, as required.</li><li>
DHPCs management: Assist in managing DHPCs, submit and track DHPCs to Regulatory Authorities (RAs)/Health Care Professionals (HCPs) (if performed by LMS)</li><li>
Support to the HUB: Provide support to the HUB for local RRAs.</li><li>
Medical/pharmaceutical assessments: Conduct medical/pharmaceutical assessments of local individual cases when requested in partnership with global teams, if applicable.</li></ul><h3 class="jobSectionHeader"><b>
Pharmacovigilance and Vigilance Service Provisions</b></h3><p>
Day-to-day PV functions</p><ul><li>
Ensure that day-to-day PV functions and safety activities for nonmedicinal products (i.e., medical devices) are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level.</li></ul><p>
Collaboration with Marketing Authorization Holders (MAH)</p><ul><li>
Collaborate with the local MAH to enable fulfillment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA&rsquo;s)) and meet their business objectives.</li></ul><p>
Training</p><ul><li>
Local Operating Company employees: Assist in performing training for Local Operating Company employees covering (pharmacological) safety aspects of products as applicable.</li><li>
Watchlist follow-up process: Assist in performing training for Local Operating Company employees covering follow-up process for concepts of special interest (Watchlist) as applicable.</li><li>
AE/PQC training: Manage AE/PQC trainings to distributors/vendors and translation of AE/PQC material, where needed. Follow up for completion of global roll-out AE/PQC training in LOC.</li></ul><p>
Agreements / Contracts containing PV Language</p><ul><li>
PSMF Annex B Listings: Assist in providing and/or reviewing quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by LOC and ensure accuracy and timelines.</li><li>
Contract Review: Support the contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.</li><li>
Oversight on Commercial and Vendor Agreements: Support the contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.</li></ul><p>
Inspection preparation &amp; support</p><ul><li>
PV Inspection Readiness: Assist in ensuring PV audit and inspection readiness on the LOC level.</li><li>
Support Inspectors/Auditors: Provide support to assist inspectors/auditors and support document requests in collaboration with the case management team.</li><li>
CAPA Content Owner: Act as CAPA Content owner and subject matter expert, own actions as required, depending on the topic.</li><li>
Follow-up Actions from Findings: Address follow-up actions from findings.</li></ul><p>
Local Literature Search</p><ul><li>
Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).</li></ul><p>
Collaborate &amp; Support</p><ul><li>
Assist in collaboration with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, QPPV Office, VP PV &amp; Medical Compliance) as appropriate.</li><li>
Where applicable, support the CSH to provide safety-related regulatory communication (e.g., response to request for information from local RAs, including the provision of information about the volume of sales or prescription, as appropriate).</li><li>
Provide technical and strategic input and participate in projects/ workstreams led by the regional GMS teams.</li><li>
Assist in providing timely and accurately PSMF contribution.</li><li>
Assist in the implementation and the maintenance of the local &ldquo;PSMF&rdquo;.</li><li>
Support Country Safety Head / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required</li><li>
Lead or support the coordination and process standardization efforts to cross-country</li><li>
collaboration with regards to Local Medical Safety activities</li><li>
Lead or support critical project works</li></ul><h3 class="jobSectionHeader"><b>
Processes &amp; Regulations</b></h3><p>
Procedural Document Design</p><ul><li>
Implementation of Global Pharma PV Documents: Ensure implementation of Global Pharma PV relevant Procedural Documents as applicable and/or assist in writing, validating, and implementing the Local Implementation Documents (LID) for Regional/International PV Standard Operating Procedures/Working Practices and verify adherence. Where appropriate, assist in developing local controlled procedures to cover local aspects of PV/Safety activities</li><li>
Document Review and Impact Assessments: Assist in procedural document review from SMEs and Area Leads, depending on the topic. Perform impact assessments and actions as required on the local level, depending on the topic.</li></ul><p>
Safety Policy/Strategy</p><ul><li>
Awareness of Regulatory Changes: Provide support to ensure awareness of changes in regulations that may have an impact on vigilance activities and responsibilities. Evaluate&ouml;the impact on local processes and inform the appropriate global and regional groups (i.e.,&ouml;QPPV office and Regional Safety Head) of any changes to local laws and regulations regarding safety.</li><li>
Implementation of New Legislation:<ul><li>
Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional</li><li>
Ensure the implementation of new legislation with local impact for LMS-owned activities, depending on topics.</li></ul></li><li>
Local Industry Associations Engagement: Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&amp;J Voice.</li></ul><p>
Safety Reporting &amp; Compliance</p><ul><li>
Assist in establishing adequate collaboration with the Local Medical Safety organization to maintain local compliance and local compliance oversight on case processing, reconciliation, and submission to RA.</li><li>
Support to provide insights into metrics to local management and LMS, lead actions as needed.</li><li>
Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable</li><li>
Collaborate with local Commercial Quality organization to ensure oversight on local CAPA with potential impact on PV.</li><li>
Support maintaining oversight of CAPAs that could impact local processes.</li></ul><h3 class="jobSectionHeader"><b>
Perform related duties as assigned by supervisor.</b></h3><ul><li><h3 class="jobSectionHeader"><b>
Assist in maintaining compliance with all company policies and procedures.</b></h3></li></ul><h3 class="jobSectionHeader"><b>
Minimum Qualification</b></h3><ul><li>
Bachelor&rsquo;s degree in medicine or pharmacy is required.</li><li>
Proven ability to prioritize workflow activities and manage multiple critical issues.</li><li>
Awareness of and familiarity with industry principles of product vigilance, drug development and pharmacology.</li><li>
Basic knowledge of Global, Regional and Local Procedural Documents as applicable.</li><li>
Computer literate with knowledge of relevant IT safety systems.</li><li>
Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.</li><li>
Ability to establish and maintain open relationships within the organization and with authorities.</li><li>
Ability to prioritize and work to strict timelines daily</li><li>
Demonstrable knowledge of all local requirements and of global aspects of product safety.</li><li>
Fluency in the national language(s) and the English language is required.</li></ul><p>
Other Requirements</p><ul><li>
Proven expertise and experience in pharmaceutical regulations and R&amp;D processes is preferred.</li><li>
By preference a minimum of 1+ years pharmaceutical industry experience in a product vigilance responsibility role</li></ul></div>

Local Medical Safety Specialist

<div><p>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
</p><p></p><p><b>Job Function:
</b></p>Product Safety
<p></p><p><b>Job Sub </b><b>Function:
</b></p>Pharmacovigilance
<p></p><p><b>Job Category:
</b></p>Scientific/Technology
<p></p><p><b>All Job Posting Locations:
</b></p>Istanbul, Turkey
<p></p><p><b>Job Description:
</b></p><p><b>About Innovative Medicine
</b></p><p>Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
</p><p>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
</p><p>Learn more at https://www.jnj.com/innovative-medicine
</p><p></p><p>We are searching for the best talent for a Medical Safety Specialist. This position will be located in Istanbul, Turkey.
</p><h2 class="jobSectionHeader"><b>Essential Job Duties and Responsibilities
</b></h2><p></p><p>The position is responsible for supporting the compliance of LOC Safety activities of TURGAN cluster by mainly focused on Turkiye, covering medicinal products, with local regulations, company policies, and global standards, including any Product vigilance agreements with third-party partners.
 </p><p>It involves assisting in establishing and maintaining effective Pharmacovigilance and Risk management systems and supporting the oversight of the products within its responsibility.
</p><p>The role includes contributing to the proactive management of Benefit Risk Management throughout the product life cycle, tailoring actions to local needs. Additionally, it involves aiding in safety reporting requirements as needed by Marketing Authorization Holders (MAH) and study sponsors, as applicable.
</p><h2 class="jobSectionHeader"><b>Safety Management &amp; Reporting
</b></h2><p>Oversight and Providing Input
</p><ul><li>Support Data-generating Activities : Assist in overseeing data-generating activities to ensure appropriate review and reporting processes are included in project documents for reporting potential Adverse Events (AEs), such as patient support programs, market research surveys, and internet sites, as applicable. Provide support to the Hub for Related Research Activities (RRA) activities, where applicable.
</li><li>Vendor Contra cts : Ensure, in collaboration with the Hub if applicable, that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
</li><li>Product Portfolio Oversight : Support the oversight of the full product portfolio and establish links with local management and key stakeholders. Assist in overseeing the safety aspects of clinical studies conducted in the territory, as applicable.
</li></ul><p></p><p>Submission to Regulatory Authority
</p><ul><li>Support the coordination of safety requirements delegated by Marketing Authorization Holders (MAH).
</li><li>Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners independently and with minimal supervision
</li><li>Independently and with minimal supervision, ensure timely submission of aggregate safety reports (e.g. DSUR, PBRERs etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
</li><li>Independently and with minimal supervision, ensure timely submission of other safety reports (e.g. DHPC, RMP etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
</li></ul><p></p><p>Signal Detection
</p><ul><li>Assist in implementing a robust local signal detection process if required and ensure the reporting of potential single case signals or clusters of similar events identified during case processing, as applicable.
</li></ul><p></p><p>Aggregate Reporting
</p><ul><li>Assist in local review and ensure the submission of Periodic Benefit Risk Evaluaiton Reports (PBRERs), providing due dates to Global Medical Safety (GMS), and promoting synchronization with the Global PSUR schedule, in accordance with national requirements and in collaboration with the local Regulatory Affairs unit.
</li><li>Products for Local Opportunity (POLOs): When Global Medical Safety (GMS) does not provide the Aggregate Reports, support the preparation of specific reports (e.g., PBRERs) if not already provided by a third party under a PV agreement, as applicable.
</li></ul><p></p><p>Business Continuity
</p><ul><li>Local Business Continuity Plans: Assist in the development and implementation of local business continuity plans (e.g., inspection readiness, Adverse Event reporting coverage) in collaboration with the case management team.
</li><li>24-hour Coverage: Support the establishment of an effective system for 24-hour coverage.
</li><li>Day-to-day Pharmacovigilance (PV) Functions: Support to ensure the satisfactory performance of day-to-day Pharmacovigilance (PV) functions and maintain optimal regulatory compliance at the Local Operating Company (LOC) level in collaboration with the case management team.
</li></ul><p></p><p>Risk Management
</p><ul><li>Implementation of Risk Management Plans: Support the implementation of Risk Management Plans and Urgent Safety Restrictions, if required.
</li></ul><p></p><p>New Safety Information
</p><ul><li>Dissemination of New Safety Information: Assist in taking appropriate measures to ensure that new safety information is available to RA and Health Care Professionals (HCP) in a timely manner, i.e., DHPC, CCDS implementation into local label, USR in collaboration with adequate partners if applicable.
</li></ul><h2 class="jobSectionHeader"><b>Benefit Risk Management
</b></h2><ul><li>Establish product knowledge: Assist in establishing product knowledge with a focus on safety profiles, therapeutic area, and disease pathway knowledge to support the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety Leader or MSO.
</li><li>Act as a safety expert: Support safety expert activities in cross-functional team meetings and conduct training on safety-relevant aspects, as appropriate.
</li><li>Risk Management Plan status updates: Assist in providing Risk Management Plan status updates.
</li><li>Local RMPs/Addendums: Support the preparation of Local RMPs/Addendums, etc. (if performed by LMS)
</li><li>Implementation of Risk Management Plans: Participate in the implementation of Risk Management Plans and Urgent Safety Restrictions, if required.
</li><li>Benefit-risk and product safety meetings: Participate in meetings with relevant partners to discuss and evaluate topics related to benefit-risk and product safety, as required.
</li><li>DHPCs management: Assist in managing DHPCs, submit and track DHPCs to Regulatory Authorities (RAs)/Health Care Professionals (HCPs) (if performed by LMS)
</li><li>Support to the HUB: Provide support to the HUB for local RRAs.
</li><li>Medical/pharmaceutical assessments: Conduct medical/pharmaceutical assessments of local individual cases when requested in partnership with global teams, if applicable.
</li></ul><h2 class="jobSectionHeader"><b>Pharmacovigilance and Vigilance Service Provisions
</b></h2><p></p><p>Day-to-day PV functions
</p><ul><li>Ensure that day-to-day PV functions and safety activities for nonmedicinal products (i.e., medical devices) are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level.
</li></ul><p></p><p>Collaboration with Marketing Authorization Holders (MAH)
</p><ul><li>Collaborate with the local MAH to enable fulfillment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA&rsquo;s)) and meet their business objectives.
</li></ul><p></p><p>Training
</p><ul><li>Local Operating Company employees: Assist in performing training for Local Operating Company employees covering (pharmacological) safety aspects of products as applicable.
</li><li>Watchlist follow-up process: Assist in performing training for Local Operating Company employees covering follow-up process for concepts of special interest (Watchlist) as applicable.
</li><li>AE/PQC training: Manage AE/PQC trainings to distributors/vendors and translation of AE/PQC material, where needed. Follow up for completion of global roll-out AE/PQC training in LOC.
</li></ul><p></p><p>Agreements / Contracts containing PV Language
</p><ul><li>PSMF Annex B Listings: Assist in providing and/or reviewing quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by LOC and ensure accuracy and timelines.
</li><li>Contract Review: Support the contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
</li><li>Oversight on Commercial and Vendor Agreements: Support the contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
</li></ul><p></p><p>Inspection preparation &amp; support
</p><ul><li>PV Inspection Readiness: Assist in ensuring PV audit and inspection readiness on the LOC level.
</li><li>Support Inspectors/Auditors: Provide support to assist inspectors/auditors and support document requests in collaboration with the case management team.
</li><li>CAPA Content Owner: Act as CAPA Content owner and subject matter expert, own actions as required, depending on the topic.
</li><li>Follow-up Actions from Findings: Address follow-up actions from findings.
</li></ul><p>Local Literature Search
</p><ul><li>Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
</li></ul><p></p><p>Collaborate &amp; Support
</p><ul><li>Assist in collaboration with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, QPPV Office, VP PV &amp; Medical Compliance) as appropriate.
</li><li>Where applicable, support the CSH to provide safety-related regulatory communication (e.g., response to request for information from local RAs, including the provision of information about the volume of sales or prescription, as appropriate).
</li><li>Provide technical and strategic input and participate in projects/ workstreams led by the regional GMS teams.
</li><li>Assist in providing timely and accurately PSMF contribution.
</li><li>Assist in the implementation and the maintenance of the local &ldquo;PSMF&rdquo;.
</li><li>Support Country Safety Head / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required
</li><li>Lead or support the coordination and process standardization efforts to cross-country
</li><li>collaboration with regards to Local Medical Safety activities
</li><li>Lead or support critical project works
</li></ul><h2 class="jobSectionHeader"><b>Processes &amp; Regulations
</b></h2><p></p><p>Procedural Document Design
</p><ul><li>Implementation of Global Pharma PV Documents: Ensure implementation of Global Pharma PV relevant Procedural Documents as applicable and/or assist in writing, validating, and implementing the Local Implementation Documents (LID) for Regional/International PV Standard Operating Procedures/Working Practices and verify adherence. Where appropriate, assist in developing local controlled procedures to cover local aspects of PV/Safety activities
</li><li>Document Review and Impact Assessments: Assist in procedural document review from SMEs and Area Leads, depending on the topic. Perform impact assessments and actions as required on the local level, depending on the topic.
</li></ul><p></p><p>Safety Policy/Strategy
</p><ul><li>Awareness of Regulatory Changes: Provide support to ensure awareness of changes in regulations that may have an impact on vigilance activities and responsibilities. Evaluate&ouml;the impact on local processes and inform the appropriate global and regional groups (i.e.,&ouml;QPPV office and Regional Safety Head) of any changes to local laws and regulations regarding safety.
</li><li>Implementation of New Legislation:
<ul><li>Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional
</li><li>Ensure the implementation of new legislation with local impact for LMS-owned activities, depending on topics.
</li></ul></li><li>Local Industry Associations Engagement: Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&amp;J Voice.
</li></ul><p></p><p>Safety Reporting &amp; Compliance
</p><ul><li>Assist in establishing adequate collaboration with the Local Medical Safety organization to maintain local compliance and local compliance oversight on case processing, reconciliation, and submission to RA.
</li><li>Support to provide insights into metrics to local management and LMS, lead actions as needed.
</li><li>Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable
</li><li>Collaborate with local Commercial Quality organization to ensure oversight on local CAPA with potential impact on PV.
</li><li>Support maintaining oversight of CAPAs that could impact local processes.
</li></ul><h2 class="jobSectionHeader"><b>Perform related duties as assigned by supervisor.
</b></h2><ul><li><h3 class="jobSectionHeader"><b>Assist in maintaining compliance with all company policies and procedures.
</b></h3></li></ul><h2 class="jobSectionHeader"><b>Minimum Qualification
</b></h2><ul><li>Bachelor&rsquo;s degree in medicine or pharmacy is required.
</li><li>Proven ability to prioritize workflow activities and manage multiple critical issues.
</li><li>Awareness of and familiarity with industry principles of product vigilance, drug development and pharmacology.
</li><li>Basic knowledge of Global, Regional and Local Procedural Documents as applicable.
</li><li>Computer literate with knowledge of relevant IT safety systems.
</li><li>Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
</li><li>Ability to establish and maintain open relationships within the organization and with authorities.
</li><li>Ability to prioritize and work to strict timelines daily
</li><li>Demonstrable knowledge of all local requirements and of global aspects of product safety.
</li><li>Fluency in the national language(s) and the English language is required.
</li></ul><p></p><p>Other Requirements
</p><ul><li>Proven expertise and experience in pharmaceutical regulations and R&amp;D processes is preferred.
</li><li>By preference a minimum of 1+ years pharmaceutical industry experience in a product vigilance responsibility role</li></ul></div><p></p>

Stryker

<div><h3 class="jobSectionHeader"><b>Why join Stryker?</b></h3>
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.<br>
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards &ndash; not to mention various social and recreational activities, all of which are location specific.<h3 class="jobSectionHeader"><b>
Job description</b></h3>
We are excited to be named one of the World&rsquo;s Best Workplaces by Fortune Magazine!
<br>
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards &ndash; not to mention various social and recreational activities, all of which are location specific.<div><p><br>
Mako is a robotic-arm-assisted procedure that helps orthopedic surgeons perform personalized total knee, partial knee or total hip surgeries.</p><p></p><p><b><br>
What you will do:</b></p><br>
<p></p><ul><li>
Complete a four-month training on working with Mako.</li><li>
Receive full training on Mako.</li><li>
Attend Mako cases and meetings with a certified Mako Product Specialist.</li><li>
After successful completion of the four-month training, you may be hired as an Associate Mako Product Specialist.</li></ul><p></p><p><b><br>
Who we look for:</b></p><br>
<p></p><ul><li>
Highly motivated individuals who want to work with high-class technology</li><li>
Individuals who are eager to learn and who pursue career in medical device industry</li><li>
B.S. degree (biomedical engineering preferred)</li>
Fluency in English<br>
<li>
</li></ul><br>
<p>Pay rate will not be below any applicable local minimum wage rates.</p></div>
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.</div>

Mako Product Specialist Trainee

Hitachi Energy

<div>
 <strong>
  The Opportunity
  <br/>
  <br/>
 </strong>
 At Hitachi Energy, our purpose is advancing a sustainable energy future for all. We bring power to our homes, schools, hospitals, and factories. Join us and work with fantastic people, while learning and developing yourself on projects that have a real impact to our communities and society. Bring your passion, bring your energy, and be part of a global team that appreciates a simple truth: Diversity + Collaboration = Great Innovation.
 <br/>
 <br/>
 <strong>
  How You Will Make An Impact
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Drive the HSE activities on facilities, workshops, warehouses to secure the alignment with legal, local official standards and Hitachi Energy global requirements and address when needed.
  </li>
  <li>
   Conduct, contribute and participate the basic concepts suchlike risk assessment (ABRA) and environmental aspects &amp; impact assessment, participate emergency drills, site walks/tours (SOT), GEMBA activities, 5S implementations etc. as a whole contribute the HSE performance, hazards, risks and precautions and take necessary actions where necessary.
  </li>
  <li>
   Support the activities to update and maintain the ISO 45001 and 14001 (contribute to update and maintain the documentations for the management), implement global and local targets, identified improvements together with RE management and the local HSE department.
  </li>
  <li>
   Organize and follow health, safety and environmental trainings for Hitachi Energy employees and Real Estate&rsquo;s contractors&rsquo; staff when and where required.
  </li>
  <li>
   Contribute to monitoring and reporting HSE performance on facility management and projects, prepare, analyze and report RE HSE periodical metrics within Hitachi Energy or other required parties and on tools like Intelex.
  </li>
  <li>
   Offer HSE insights and recommendations for ongoing and upcoming projects.
  </li>
  <li>
   Promote safety culture and behavior change initiatives and implementing new projects.
  </li>
  <li>
   Control, set, improve HSE methodology for RE scope of works especially facility management and catering routine services.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Your Background
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in a related fields. Environmental, Electrical,Maechanical,Civil Engineering is a plus.
  </li>
  <li>
   Having min. C-class Occupational Safety Specialist,
  </li>
  <li>
   Min. 5 years experience of HSE systems implementations at industrial facilities,
  </li>
  <li>
   Familiar with ISO 14001 and ISO 45001,NEBOSH and NFPA,
  </li>
  <li>
   Good command of written and spoken English &amp; Turkish,
  </li>
  <li>
   Preferably with experience in construction or facility management.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  More About Us
  <br/>
  <br/>
 </strong>
 We pride ourselves on offering a holistic range of competitive benefit programs to support your financial, physical and mental wellbeing and personal development. We want you to truly thrive with us &ndash; in work and out.
 <br/>
 <br/>
 For this role, depending on grade and experience, we offer the following employee benefits;
 <br/>
 <br/>
 <ul>
  <li>
   Access to a comprehensive wellbeing program,
  </li>
  <li>
   Private health insurance,
  </li>
  <li>
   Transportation allowance.
   <br/>
   <br/>
  </li>
 </ul>
 Hitachi Energy is a global technology leader in electrification, powering a sustainable energy future through innovative power grid technologies with digital at the core. Over three billion people depend on our technologies to power their daily lives.
 <br/>
 <br/>
 With over a century in pioneering mission-critical technologies like high-voltage, transformers, automation, and power electronics, we are addressing the most urgent energy challenge of our time &ndash; balancing soaring electricity demand, while decarbonizing the power system.
 <br/>
 <br/>
 Headquartered in Switzerland, we employ over 50,000 people in 60 countries and generate revenues of around $16 billion USD. We welcome you to apply today.
</div>


Environmental and Employee Health & Safety Specialist

Takeda Pharmaceuticals

<div><p>By clicking the &ldquo;Apply&rdquo; button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda&rsquo;s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.</p><p></p><h2 class="jobSectionHeader"><b>
Job Description</b></h2><p></p><p><b>
Job Purpose</b></p><p></p><p><br>
Act as a trusted scientific partner in the field by engaging healthcare professionals in peer-to-peer scientific exchange, driving insights collection, and supporting local evidence generation, under the strategic guidance of the Medical Manager and in alignment with the Medical Affairs plan.</p><p></p><p><b>
Role Core Responsibilities &amp; Accountabilities</b></p><p></p><ul><li>
Establish and maintain peer-to-peer relationships with HCPs, acting as a scientific resource and trusted partner in assigned territory.</li><li>
Plan and execute territory-level KOL engagement aligned with the local medical plan, brand strategy, and scientific priorities.</li><li>
Facilitate timely, accurate, fair-balanced scientific exchange and medical education aligned with compliance standards.</li><li>
Gather, analyze, and share actionable medical insights from HCPs to inform cross-functional planning and R&amp;D alignment.</li><li>
Represent Takeda at scientific meetings and congresses, providing internal summaries and follow-up insights.</li><li>
Deliver training on disease area, clinical data, and product information to commercial, access, regulatory, and patient services colleagues.</li><li>
Provide scientific support for company-sponsored clinical trials and investigator-initiated research, including feasibility, site interaction, and education.</li><li>
Maintain updated knowledge of therapeutic area and treatment landscape, contributing to internal medical intelligence.</li><li>
Accurately document field activities and HCP interactions using CRM tools, ensuring alignment with SOPs and compliance policies.</li><li>
Collaborate with cross-functional teams to support local initiatives such as advisory boards, speaker training, and patient-focused projects.</li></ul><p></p><p><b>
Role Mandatory Responsibilities</b></p><p></p><ul><li>
To act in-line with Takeda&rsquo;s &ldquo;Information Security Policy&rdquo; and &ldquo;Acceptable Use of Technology Policy&rdquo;.</li><li>
Being a Quality and Safety Ambassador by identifying and promptly communicating product quality and pharmacovigilance issues to appropriate internal teams.</li><li>
Excels in ethical behavior by consistently acting with integrity and serving as a role model for Takeda-ism values and ethical decision-making.</li><li>
Training &amp; Compliance: Ensure full and timely completion of all mandatory Takeda training requirements and compliance with global, regional, and local procedures and SOPs.</li><li>
Speak-up for Integrity: Encourage a culture of openness by raising any concerns in good faith via the Ethics Line, to line management or directly to Ethics &amp; Compliance.</li></ul><p></p><p>
Job Dimension</p><ul><li>
OPEX responsibility: YES</li><li>
Financial Responsibility: YES</li><li>
Volume Impact: No</li><li>
Revenue Impact: No</li></ul><p></p><p>
Role required Qualifications &amp; Capabilities</p><ul><li>
University degree in Medicine or Pharmacy, advanced scientific degree preferred.</li><li>
Demonstrated ability to effectively engage and communicate with KOLs and external medical stakeholders.</li><li>
Highly qualified presentation skills</li><li>
Strong verbal and written communication skills in English and local language.</li><li>
Understanding of relevant therapeutic area, clinical data interpretation, and real-world evidence.</li><li>
Excellent planning, time management, and prioritization skills in a remote/field-based setup.</li><li>
Digital literacy in CRM systems, Microsoft Office, and virtual communication tools.</li><li>
Strong ethical standards and compliance-driven mindset.</li><li>
Minimum 2 years of experience in Medical Affairs or relevant clinical/research environment in the pharmaceutical industry is preferred.</li></ul><p></p><h2 class="jobSectionHeader"><b>
Locations</b></h2>
Istanbul, TurkeyAnkara, Turkey<p></p><h2 class="jobSectionHeader"><b>
Worker Type</b></h2>
Employee<p></p><h2 class="jobSectionHeader"><b>
Worker Sub-Type</b></h2>
Regular<p></p><h2 class="jobSectionHeader"><b>
Time Type</b></h2>
Full time</div>

Medical Science Liaison (HAE)

<div><p>By clicking the &ldquo;Apply&rdquo; button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda&rsquo;s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.</p><p></p><h2 class="jobSectionHeader"><b>
Job Description</b></h2><p></p><p>
Job Purpose</p><p></p><p>
Act as a trusted scientific partner in the field by engaging healthcare professionals in peer-to-peer scientific exchange, driving insights collection, and supporting local evidence generation, under the strategic guidance of the Medical Manager and in alignment with the Medical Affairs plan.</p><p></p><p>
Role Core Responsibilities &amp; Accountabilities</p><p></p><ul><li>
Establish and maintain peer-to-peer relationships with HCPs, acting as a scientific resource and trusted partner in assigned territory.</li><li>
Plan and execute territory-level KOL engagement aligned with the local medical plan, brand strategy, and scientific priorities.</li><li>
Facilitate timely, accurate, fair-balanced scientific exchange and medical education aligned with compliance standards.</li><li>
Gather, analyze, and share actionable medical insights from HCPs to inform cross-functional planning and R&amp;D alignment.</li><li>
Represent Takeda at scientific meetings and congresses, providing internal summaries and follow-up insights.</li><li>
Deliver training on disease area, clinical data, and product information to commercial, access, regulatory, and patient services colleagues.</li><li>
Provide scientific support for company-sponsored clinical trials and investigator-initiated research, including feasibility, site interaction, and education.</li><li>
Maintain updated knowledge of therapeutic area and treatment landscape, contributing to internal medical intelligence.</li><li>
Accurately document field activities and HCP interactions using CRM tools, ensuring alignment with SOPs and compliance policies.</li><li>
Collaborate with cross-functional teams to support local initiatives such as advisory boards, speaker training, and patient-focused projects.</li></ul><p></p><p>
Role Mandatory Responsibilities</p><p></p><ul><li>
To act in-line with Takeda&rsquo;s &ldquo;Information Security Policy&rdquo; and &ldquo;Acceptable Use of Technology Policy&rdquo;.</li><li>
Being a Quality and Safety Ambassador by identifying and promptly communicating product quality and pharmacovigilance issues to appropriate internal teams.</li><li>
Excels in ethical behavior by consistently acting with integrity and serving as a role model for Takeda-ism values and ethical decision-making.</li><li>
Training &amp; Compliance: Ensure full and timely completion of all mandatory Takeda training requirements and compliance with global, regional, and local procedures and SOPs.</li><li>
Speak-up for Integrity: Encourage a culture of openness by raising any concerns in good faith via the Ethics Line, to line management or directly to Ethics &amp; Compliance.</li></ul><p></p><p>
Job Dimension</p><ul><li>
OPEX responsibility: YES</li><li>
Financial Responsibility: YES</li><li>
Volume Impact: No</li><li>
Revenue Impact: No</li></ul><p></p><p>
Role required Qualifications &amp; Capabilities</p><ul><li>
University degree in Medicine or Pharmacy, advanced scientific degree preferred.</li><li>
Demonstrated ability to effectively engage and communicate with KOLs and external medical stakeholders.</li><li>
Highly qualified presentation skills</li><li>
Strong verbal and written communication skills in English and local language.</li><li>
Understanding of relevant therapeutic area, clinical data interpretation, and real-world evidence.</li><li>
Excellent planning, time management, and prioritization skills in a remote/field-based setup.</li><li>
Digital literacy in CRM systems, Microsoft Office, and virtual communication tools.</li><li>
Strong ethical standards and compliance-driven mindset.</li><li>
Minimum 2 years of experience in Medical Affairs or relevant clinical/research environment in the pharmaceutical industry is preferred.</li></ul><p></p><h2 class="jobSectionHeader"><b>
Locations</b></h2>
Istanbul, TurkeyAnkara, Turkey<p></p><h2 class="jobSectionHeader"><b>
Worker Type</b></h2>
Employee<p></p><h2 class="jobSectionHeader"><b>
Worker Sub-Type</b></h2>
Regular<p></p><h2 class="jobSectionHeader"><b>
Time Type</b></h2>
Full time</div>

Medical Science Liaison - Rare Genetic Diseases

<div></div><div><div><div><h2 class="jobSectionHeader"><b>Become our next FutureStarter</b></h2><p>
Are you ready to make an impact? ZF is looking for talented individuals to join our team. As a FutureStarter, you&rsquo;ll have the opportunity to shape the future of mobility. Join us and be part of something extraordinary!</p>
</div></div><div><div><div><div><h1 class="jobSectionHeader"><b>Accounting Specialist
</b></h1></div></div></div></div><div><div><div><div>Country/Region: TR
</div></div></div></div><div><div><div><div>Location:
Istanbul, Istanbul, TR, 34935
</div></div></div></div><p></p><div><div><div><div><p>Req ID 81541 | Istanbul, T&uuml;rkiye, ZF Services T&uuml;rk San. ve Tic. A.&#350;.</p><br>
<p></p>
<div><div><div><h2 class="jobSectionHeader"><b>
Accounting Specialist</b></h2>
</div><div><p><b>
About the Team:</b></p>
<p>
We are expanding our Finance, Accounting and Controlling team across Istanbul and looking for Accounting Specialist to join us in Istanbul with Division Aftermarket.</p>
<p><b>
What you can look forward to as Accounting Specialist:</b></p>
<ul>
<li>Ensure all financial transactions are processed in compliance with local GAAP and company policies.</li>
<li>Review and manage tax calculations, fillings, and compliance requirements.</li>
<li>Oversee fixed asset accounting, including capitalization, depreciation, and disposals.</li>
<li>Conduct daily reviews of accounting entries to ensure accuracy and completeness.</li>
<li>Collaborate with the sales department to manage financial instruments, including Letters of Guarantee and Direct Payment Systems.</li>
<li>Maintain records and processes related to other financial necessities and regulatory requirements.</li>
<li>Support month-end and year-end closings, ensuring timely and accurate reporting.</li>
<li>Identify areas for process improvement within the accounting function and recommend solutions.</li>
<li>Build and maintain strong relationships with internal and external stakeholders.</li>
</ul>
<p><b>Your profile as Accounting Specialist:</b></p>
<ul>
<li>Bachelor&rsquo;s degree in Accounting, Finance, or a related field.</li>
<li>Min 7-8 years experience in accounting roles, preferably with exposure to local GAAP standards.</li>
<li>Strong knowledge of tax regulations and compliance requirements.</li>
<li>Experience with fixed asset management and accounting processes.</li>
<li>Proficiency in ERP systems (e.g., SAP, Navision) and advanced Excel skills.</li>
<li>Advanced English language skills in both written and verbal communication.</li>
<li>Excellent analytical and problem-solving skills.</li>
<li>Customer-oriented mindset with the ability to collaborate effectively across departments.</li>
<li>Strong organizational skills and attention to detail.</li>
<li>Ability to work under tight deadlines and manage multiple priorities effectively.</li>
</ul>
<p><b>Why you should choose ZF:</b></p>
<ul>
<li>An employment contract in a stable, global company.</li>
<li>Hybrid system work (depends on the position).</li>
<li>Private health insurance and employee package.</li>
<li>Good working atmosphere; working in an international team, interesting projects, and tasks.</li>
</ul>
<p><b>ERP:</b> The position is part of the ZF Global Employee Referral Program.</p></div></div></div><p>
Be part of our ZF team as Accounting Specialist and apply now!</p><br>
<p></p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>What does DEI (Diversity, Equity, Inclusion) mean for ZF as a company?</b></h2><p>
At ZF, we continuously strive to build and maintain a culture where inclusiveness is lived and diversity is valued. We actively seek ways to remove barriers so that all our employees can rise to their full potential. We aim to embed this vision in our legacy through how we operate and build our products as we shape the future of mobility.</p>
</div></div><div><div><p>Find out how we work at ZF:</p><br>
</div></div><div></div><p><br>
<b>Job Segment: </b>Compliance, Business Process, Accounting, ERP, Law, Legal, Management, Technology, Finance</p></div>

Accounting Specialist

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