drug safety specialist

Syneos Health

<div>
 
 Description
 
 
 
 Safety &amp; PV Specialist II (Literature Review)
 
 
 Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
 
 
 Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
 
 
 Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
 
 
 Discover what our 29,000 employees, across 110 countries already know:
 
 
 
 WORK HERE MATTERS EVERYWHERE
 
 
 
 Why Syneos Health
 
 
 <ul>
 <li>
 We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
 </li>
 <li>
 We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
 </li>
 <li>
 We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.
 
 
 </li>
 </ul>
 
 Job Responsibilities
 
 
 
 
 JOB RESPONSIBILITIES
 
 
 
 <ul>
 <li>
 Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
 </li>
 <li>
 Skilled in extracting and summarizing key safety information from identified literature sources
 </li>
 <li>
 Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.
 </li>
 <li>
 In depth knowledge of major literature databases such as Embase, PubMed etc.
 </li>
 <li>
 Experience in conducting local literature searches and reviews.
 </li>
 <li>
 Understanding of regulatory requirements with respect to global and local literature.
 </li>
 <li>
 Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
 </li>
 <li>
 May assist in the preparation of the Safety Management Plan
 </li>
 <li>
 Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
 </li>
 <li>
 Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
 </li>
 <li>
 Enters data into safety database.
 </li>
 <li>
 Codes events, medical history, concomitant medications and tests.
 </li>
 <li>
 Compiles complete narrative summaries.
 </li>
 <li>
 Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
 </li>
 <li>
 Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
 </li>
 <li>
 Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
 </li>
 <li>
 Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
 </li>
 <li>
 Participate in audits/inspections as required
 </li>
 <li>
 Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
 </li>
 <li>
 Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
 
 
 </li>
 </ul>
 Good communication and interpersonal skills, both written and spoken
 
 
 Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
 
 
 
 What We&rsquo;re Looking For
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s Degree, Postgraduate in health profession with relevant experience, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
 </li>
 <li>
 At least 3+ years of experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal &amp; AR) report from Literature.
 </li>
 <li>
 Mandatory to have GVP Module 6 knowledge
 </li>
 <li>
 Safety Database systems and knowledge of medical terminology required
 </li>
 <li>
 Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
 </li>
 <li>
 Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
 </li>
 <li>
 Ability to work independently and in a team environment
 </li>
 <li>
 Good communication and interpersonal skills, both written and spoken
 </li>
 <li>
 Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
 </li>
 <li>
 Detail oriented with a high degree of accuracy and ability to meet deadlines
 </li>
 <li>
 Minimal travel may be required (up to 5%)
 
 
 </li>
 </ul>
 
 Get to know Syneos Health
 
 
 
 Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
 
 
 No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
 
 
 http://www.syneoshealth.com
 
 
 
 Additional Information
 
 
 
 Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
 
 
 
 Summary
 
 
 
 Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
</div>

Safety & PV Specialist II (Literature Review)

Alpha-9 Oncology

<div>
 
 Your Impact
 
 
 
 Alpha-9 Oncology is seeking a Pharmacovigilance Scientist to support drug safety activities across our early-phase clinical programs. You will establish foundational processes and operations, oversee vendor-delivered case processing, and ensure compliance with global safety requirements. This hands-on role offers the opportunity to shape how PV operations are built and scaled in a growing clinical stage radiopharmaceutical company.
 
 
 
 How You'll Contribute
 
 
 
 <ul>
 <li>
 Serve as the internal lead for PV operations, partnering with CROs, internal and external medical safety experts to ensure timely and accurate case processing, reconciliation, and safety reporting.
 </li>
 <li>
 Manage the collection, review, and quality oversight of safety data from clinical trials, including expedited and periodic reporting to regulatory authorities.
 </li>
 <li>
 Conduct and document literature surveillance and aggregate safety data review to identify potential safety signals.
 </li>
 <li>
 Support development of safety sections of regulatory documents (e.g., investigator brochures, DSURs, clinical study reports).
 </li>
 <li>
 Maintain inspection-ready safety documentation and contribute to the authoring and updating of PV SOPs and work instructions.
 </li>
 <li>
 Collaborate with Clinical Operations, Regulatory Affairs, and Quality to align safety processes with overall program execution.
 </li>
 <li>
 Contribute to vendor oversight, including review of safety deliverables, metrics, and compliance reports.
 
 
 </li>
 </ul>
 
 The Skills You Bring
 
 
 
 <ul>
 <li>
 Advanced degree (PharmD, RN, Ph.D., MPH, or MS) in a scientific or health-related field.
 </li>
 <li>
 3+ years of pharmacovigilance experience in biotech, pharma, or CRO settings.
 </li>
 <li>
 Hands-on experience with case processing, safety data reconciliation, and aggregate report contributions.
 </li>
 <li>
 Knowledge of global PV requirements (ICH, FDA, EMA, CIOMS, TGA) with practical application in early-phase clinical studies.
 </li>
 <li>
 Strong analytical and written communications kills, with the ability to synthesize and interpret safety data.
 </li>
 <li>
 Experience with CROs and vendors in a lean, fast-paced, early-stage biotech environment.
 </li>
 <li>
 Familiarity with safety databases and Microsoft Office tools.
 
 
 </li>
 </ul>
 
 What's In It For You
 
 
 
 At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
 
 
 
 Company Summary
 
 
 
 Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
 
 
 Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
 
 
 
 More About Alpha-9 Oncology
 
 
 
 Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
 
 
 We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
</div>

Scientist, Pharmacovigilance

Pfizer

<div><div>In this pharmacovigilance role, you will carry out processing activities of Individual Case Safety Reports (both clinical trials and post-marketing sources) in the ARGUS Safety database.</div><div>
Processing activities include assessing case validity, undertaking duplicate checks, creating cases in the database, prioritizing cases as per company guidance, updating cases with information provided in XML source documents, identifying adverse events, confirming their seriousness, coding products, undertaking causality and listedness assessments, drafting narratives, determining appropriate case follow-up, reviewing processed cases to verify technical judgment, accuracy, and compliance with company requirements, etc.</div><div></div><div>
Here Is What You Need (Minimum Requirements):</div><div></div><div>
Education = B. Pharm, M. Pharm, or Pharm. D only.</div><div>
Experience = FRESHERS ONLY!</div><div>
Keen attention to detail.</div><div>
Solid analytical skills.</div><div>
Good written and oral communication skills.</div><div>
Collaborative skills.</div><div>
Continuous Learning.</div><div></div><div>
Bonus Points If You Have (Preferred Requirements):</div><div></div><div>
Course completion and/or certification in Pharmacovigilance or good knowledge of medical terminology and global regulatory requirements for drug safety.</div><div>
Publications in peer reviewed journals.</div><div> 
 
Work Location Assignment: Hybrid.</div> 
 
Work Location Assignment: Hybrid<div></div><div> 
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</div><div></div>
Medical</div><div></div>

Associate Safety Data Management Specialist

<div>Description
Safety &amp; PV Specialist II (Literature Review)
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities
JOB RESPONSIBILITIES
<ul><li>Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.</li><li>Skilled in extracting and summarizing key safety information from identified literature sources</li><li>Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.</li><li>In depth knowledge of major literature databases such as Embase, PubMed etc.</li><li>Experience in conducting local literature searches and reviews.</li><li>Understanding of regulatory requirements with respect to global and local literature.</li><li>Enters information into PVG quality and tracking systems for receipt and tracking ICSR.</li><li>May assist in the preparation of the Safety Management Plan</li><li>Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.</li></ul>
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. 
o Enters data into safety database. 
o Codes events, medical history, concomitant medications and tests. 
o Compiles complete narrative summaries. 
o Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. 
o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. 
o Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. 
<ul><li>Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.</li><li>Participate in audits/inspections as required</li><li>Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.</li><li>Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.</li></ul>
 Good communication and interpersonal skills, both written and spoken 
 Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
What we&rsquo;re looking for<div><ul><li> 
Bachelor&rsquo;s Degree, Postgraduate in health profession with relevant experience, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.</li></ul></div><ul><li>At least 3+ years of experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal &amp; AR) report from Literature.</li><li>Mandatory to have GVP Module 6 knowledge
</li><li>Safety Database systems and knowledge of medical terminology required</li><li>Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance</li><li>Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.</li><li>Ability to work independently and in a team environment</li><li>Good communication and interpersonal skills, both written and spoken</li><li>Good organizational skills with proven ability to prioritize and work on multiple tasks and projects</li><li>Detail oriented with a high degree of accuracy and ability to meet deadlines</li><li>Minimal travel may be required (up to 5%)</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.</div>

<div>Description
Sr Safety Specialist (Literature Review)
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.</li><li>Skilled in extracting and summarizing key safety information from identified literature sources</li><li>Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.</li><li>In depth knowledge of major literature databases such as Embase, PubMed etc.</li><li>Experience in conducting local literature searches and reviews.</li><li>Understanding of regulatory requirements with respect to global and local literature.</li><li>Coordinating workflow to ensure delivery of project.</li><li>Prepares Safety Management Plan.</li><li>Assists in the preparation and participates in internal project review meetings as required.</li><li>May enter information into PVG quality and tracking systems for receipt and tracking ICSR.</li><li>May process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans.</li></ul>
 o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. 
 o Enters data into safety database. 
 o Codes events, medical history, concomitant medications and tests. 
 o Compiles complete narrative summaries. 
 o Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. 
 o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. 
 o Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases 
<ul><li>Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.</li><li>Provides training of Investigators on ICSR reporting</li><li>Participate in audits/inspections as required</li><li>Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.</li><li>Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.</li></ul><div> 
What we&rsquo;re looking for 
<ul><li>Bachelor&rsquo;s Degree, Postgraduate in health profession with relevant experience, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.</li><li>Minimum 5 years of relevant experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal &amp; AR) report from Literature.</li><li>Strong exposure to quality checks, citation reviews, and leading internal meetings.</li><li>Experience in mentoring/training, work allocation, workflow management, and QC function oversight.</li><li>Strong communication skills and solid understanding of medical terminologies and literature review process.</li><li>Safety Database systems and knowledge of medical terminology required</li><li>In depth understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance</li><li>Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.</li><li>Ability to work independently and in a team environment</li><li>Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects</li><li>Detail oriented with a high degree of accuracy and ability to meet deadlines</li><li>Able to make effective decisions</li><li>Minimal travel may be required (up to 10%)</li></ul></div>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Sr Safety Specialist (Literature Review)

Acino

<div>Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. 
This position is based in Cairo, Egypt and will report directly to the Pharmacovigilance Head META. The role will be responsible for monitoring, assessing, and reporting the safety of pharmaceutical products, ensuring compliance with global regulatory standards. 


Your Responsibilities will be: 
Safety Data Exchange Agreements (SDEAs)
<ul>
<li>Draft, negotiate, and maintain SDEAs with business partners in META region in compliance with corporate and regulatory requirements.</li>
<li>Ensure timely execution and periodic review of SDEAs, including reconciliation of safety responsibilities and timelines in coordination with GPV.</li>
<li>Track SDEA obligations and ensure alignment with internal SOPs and global PV standards.</li>
<li>Coordinate with legal, regulatory, and compliance teams to ensure contract integrity and audit readiness.</li></ul> 


Business Partner (BP) Communication
<ul>
<li>Act as the primary PV liaison for regional business partners, distributors, and license holders.</li>
<li>Ensure timely exchange of safety data and compliance with agreed pharmacovigilance obligations.</li>
<li>Provide PV Onboarding/Refreshing training to BPs in alignment with global procedures.</li>
<li>Monitor BP compliance metrics and escalate deviations or risks as needed.</li></ul> 


Management of Internal CAPAs and deviations
<ul>
<li>Managing internal CAPAs and deviations in TrackWise, documenting quality events, assigning corrective actions, tracking progress, and ensuring compliance through automated workflows and audit-ready records.</li></ul> 


Global PSMF Maintenance
<ul><li>Ensure Global PSMF remains accurate, up-to-date, and compliant with regulatory requirements across all applicable regions.</li>
<li>Maintain the regional annexes of the Global Pharmacovigilance System Master File (PSMF)</li></ul> 


Assigned tasks from GPV responsibilities
<ul>
<li>Conduct regular screening of scientific and medical literature to identify potential adverse events and ensure compliance with global pharmacovigilance requirements</li>
<li>Prepare and review periodic safety update reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and other aggregate safety reports to summarize the benefit-risk profile of medicinal products.</li>
<li>Develop and maintain risk management plans (RMPs) to proactively identify, assess, and mitigate safety risks associated with pharmaceutical products.</li>
<li>Perform signal detection and evaluation activities to identify new safety concerns and trends from various data sources</li>
<li>Performs other tasks under direction of Director PV Operations if requested.</li></ul> 


SOPs management
<ul>
<li>Oversee the development, implementation, and periodic review of pharmacovigilance Standard Operating Procedures (SOPs) to ensure regulatory compliance, operational consistency, and alignment with global quality standards.</li></ul> 


Your Profile: 
<ul>
<li>
A university degree in Pharmacy, Medicine, Life Sciences, or related field.</li>
<li>Minimum 5-8 years&rsquo; experience in pharmacovigilance, with direct experience managing SDEAs and partner communications.</li>
<li>Excellent user of MS Office applications (Word, Excel, PowerPoint, Outlook).</li>
<li>Ability to learn about new technologies, strategies and policies, with high level of compliance with policies. Experience with electronic systems and databases.</li>
<li>Fluent in English, both in oral and in writing.</li>
<li>Full understanding of legal/compliance environment and requirements.</li></ul> 


This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</div>

Senior Pharmacovigilance (PV) Specialist META

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