pharmacovigilance specialist

EVA pharma

<div>
 <p>
  Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 </p>
 <p>
  <strong>
   Job Summary
   <br/>
   <br/>
  </strong>
  We are looking for a dedicated
  <strong>
   QPPV Specialist
  </strong>
  to join our dynamic Pharmacovigilance team. The ideal candidate will be responsible for ensuring the safety and efficacy of our products, as well as maintaining compliance with regulatory requirements.
 </p>
 <p>
  <strong>
   Key Responsibilities:
  </strong>
 </p>
 <ul>
  <ul>
   <li>
    Ensure the&nbsp;PSMF&nbsp;&amp;PSSF are&nbsp;accurate, up-to-date, and aligned with SFDA requirements.&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Manages timely collection, assessment, and submission of ICSRs to the SFDA&nbsp;within legal timelines.&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Ensure continuous monitoring of safety signals and management of emerging safety issues.&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Act as the single PV contact point for the SFDA and PV inspections (24/7 availability).&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Ensure compliance with all national pharmacovigilance requirements, risk minimization measures, and safety communication obligations.&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Ensure&nbsp;timely&nbsp;&nbsp;SFDA&nbsp;submission of PSUR/PBRER, RMP, DHPC, and any safety-related regulatory requests.&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Create and maintain local PV SOPs covering all SFDA-required PV activities.&nbsp;
   </li>
  </ul>
  <ul>
   <li>
    Participate in audits, CAPA planning, and implementation of corrective/preventive measures.&nbsp;
    <br/>
    <br/>
   </li>
  </ul>
 </ul>
 <strong>
  Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <ul>
   <li>
    Bachelor's degree or higher in Pharmacy or Medicine
   </li>
   <li>
    Licensed by the Saudi Commission for Health Specialties
   </li>
   <li>
    Full-time resident in Saudi Arabia (KSA)
   </li>
   <li>
    Pharmacovigilance experience preferred
   </li>
   <li>
    PV training in ICSR processing and MedDRA coding preferred
   </li>
   <li>
    PV training in signal detection preferred
   </li>
   <li>
    Knowledge/training in PSUR/PBRER, RMP, PSMF, and KSA PV regulations preferred
   </li>
  </ul>
 </ul>
</div>


QPPV Specialist

Merck KGaA

<p></p><div><p>Work Your Magic with us!</p><p></p><p><br>
Ready to explore, break barriers, and discover more? We know you&rsquo;ve got big plans &ndash; so do we! Our colleagues across the globe love innovating with science and technology to enrich people&rsquo;s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.</p><p></p><p><br>
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.</p><p></p><p><b><br>
Your Role:
</b></p><p>Are you passionate about patient safety and looking to make a significant impact in the field of pharmacovigilance? An exciting opportunity has opened up with our company. We are looking to hire a Patient Safety Center Associate and Local Safety Responsible (LSR) for Egypt based locally in the country for the Patient Safety Center Africa.</p><p>
Responsibilities:</p><ul><li>
All Pharmacovigilance (PV) related tasks in Egypt where this role will be nominated as local Safety Responsible (LSR) to Egypt Health Authority.
</li><li>Collaborate with a team handling PV activity across other African countries. This is a unique opportunity to work cross-functionally at both local and global levels, driving initiatives that enhance patient safety.</li><li>
As a Patient Safety Center Associate, you will be an integral part of our regional organization, the Patient Safety Center Africa and will be responsible to ensure that individual case safety reports from the local market are appropriately processed and followed up.
</li><li>This role will be responsible for the establishment and maintenance of the marketing authorization holder &lsquo;s pharmacovigilance system while maintaining promoting and improving compliance with local regulatory requirements.</li><li>
Maintain the local PV documentation of the PV systems and perform PV training as applicable. You will contribute to local audits and inspections and will support the preparation of local Risk Management Plan and submission of local aggregate safety report where applicable.
</li><li>Monitor the local PV regulation and properly follow up on the generated activities.</li><li>
Uploading new information, updating records, necessary registrations and submissions to regulators systems with good understanding of Safety Databases.</li><li>
Implementation of PV agreements and perform the required PV activities related to Patient Data collection systems and Clinical studies.</li><li>
Collaborate closely with the Global Organizations as well as the cross-functional teams (local Management, QA, Medical Affairs, Regulatory Affairs Business Unit)</li></ul><p><b>
Who you are:
</b></p><ul><li>Bachelor Degree of Pharmacy or Medicine.</li><li>
Fluent in written and spoken local language and English.</li><li>
4/5 years in PV or in the pharma industry. Health authority experience is an advantage.</li><li>
Understand business needs, think strategically, and develop risk mitigation strategies.</li><li>
High level of dedication and a strong willingness to perform.</li><li>
You are curious, obsessed with customers and patients and act as the owner to make the right decision while keeping in mind the Company&rsquo;s best interests.</li></ul><p></p><p><b><br>
What we offer:</b> We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!</p><p></p><p><br>
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!</p></div>

Patient Safety Center Associate Manager

Fresenius Medical Care

<div>
 At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision&mdash;&ldquo;Creating a future worth living. For patients. Worldwide. Every day.&rdquo;&mdash;we work with purpose and compassion, supported by a global team of over 125,000 employees.
 <br/>
 <br/>
 Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
 <br/>
 <br/>
 Our values guide how we work:
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   We Care for our patients, each other, and our communities
  </li>
  <li>
   We Connect across teams and borders to deliver excellence together
  </li>
  <li>
   We Commit to doing things the right way&mdash; growing with purpose and leading kidney care with integrity and innovation
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 Systems, Quality &amp; Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care&rsquo;s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!
 <br/>
 <br/>
 Your Responsibilities:
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Perform all country/region regulatory activities, ensuring product conformity, safety, post-market surveillance, and alignment with corporate SysQaRa and Quality functions
  </li>
  <li>
   Drive market access by preparing/adapting registration dossiers, managing submissions with consultants/TPIs, supporting due diligence, and enabling timely, compliant approvals for new and existing products
  </li>
  <li>
   Act as the primary regulatory key person, providing strategic guidance, risk assessments, and updates on national/regional regulatory requirements, while ensuring internal implementation and database maintenance
  </li>
  <li>
   Submitting notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
  </li>
  <li>
   Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements.
  </li>
  <li>
   Create and maintain local/regional registration database
  </li>
  <li>
   Identify regulatory and compliance risks, propose mitigation strategies, and track CAPAs resulting from internal or TPI audits
  </li>
  <li>
   Serve as PVRP or PV contact for assigned countries, interfacing with authorities, healthcare professionals, distributors, and CDS, and acting as the PV lead during audits/inspections
  </li>
  <li>
   For countries acting as PVRP, preparation of CAPAs for audit findings and process deviations, collection and forwarding of AE/ADRs and completion of quarterly compliance reports; for countries acting as PV point of contact, ensure preparation of CAPAs for audit findings and process deviations by the distributor and/or consultant, follow up of necessary AE/ADR collection and quarterly compliance report preparations to be performed by the related TPIs/contractors.
  </li>
  <li>
   Performing implementation and maintenance of Pharmacovigilance Agreements
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 Your Profile:
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Pharmacy, Chemistry, Biology, Bioengineering, Health Sciences, or another relevant scientific discipline
  </li>
  <li>
   At least 5 years of professional experience in regulatory affairs and at least 2 years in pharmacovigilance
  </li>
  <li>
   Results-driven professional with a structured approach, strong problem-solving and analytical skills, and the ability to handle pressure and prioritize effectively. Excellent communicator, independent worker, and solution-focused in achieving quality outcomes
  </li>
  <li>
   Demonstrated drive for process improvement and continuous optimization
  </li>
  <li>
   Solid knowledge of pharmacovigilance and pharmaceutical legislation
  </li>
  <li>
   Proficient in English (spoken and written)
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 Our Offer for you:
 <br/>
 <br/>
 There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
  </li>
  <li>
   Individual opportunities for self-determined career planning and professional development
  </li>
  <li>
   A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
  </li>
  <li>
   A large number of committed people with a wide range of skills, talents and experience
  </li>
  <li>
   The benefits of a successful global corporation with the collegial culture of a medium-sized company
  </li>
 </ul>
</div>


Regulatory and Pharmacovigilance Senior Expert

Merck Healthcare

<div>
 Work Your Magic with us!
 <br/>
 <br/>
 Ready to explore, break barriers, and discover more? We know you&rsquo;ve got big plans &ndash; so do we! Our colleagues across the globe love innovating with science and technology to enrich people&rsquo;s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
 <br/>
 <br/>
 United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
 <br/>
 <br/>
 <strong>
  Your Role
  <br/>
  <br/>
 </strong>
 Are you passionate about patient safety and looking to make a significant impact in the field of pharmacovigilance? An exciting opportunity has opened up with our company. We are looking to hire a Patient Safety Center Associate and Local Safety Responsible (LSR) for Egypt based locally in the country for the Patient Safety Center Africa.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   All Pharmacovigilance (PV) related tasks in Egypt where this role will be nominated as local Safety Responsible (LSR) to Egypt Health Authority.
  </li>
  <li>
   Collaborate with a team handling PV activity across other African countries. This is a unique opportunity to work cross-functionally at both local and global levels, driving initiatives that enhance patient safety.
  </li>
  <li>
   As a Patient Safety Center Associate, you will be an integral part of our regional organization, the Patient Safety Center Africa and will be responsible to ensure that individual case safety reports from the local market are appropriately processed and followed up.
  </li>
  <li>
   This role will be responsible for the establishment and maintenance of the marketing authorization holder &lsquo;s pharmacovigilance system while maintaining promoting and improving compliance with local regulatory requirements.
  </li>
  <li>
   Maintain the local PV documentation of the PV systems and perform PV training as applicable. You will contribute to local audits and inspections and will support the preparation of local Risk Management Plan and submission of local aggregate safety report where applicable.
  </li>
  <li>
   Monitor the local PV regulation and properly follow up on the generated activities.
  </li>
  <li>
   Uploading new information, updating records, necessary registrations and submissions to regulators systems with good understanding of Safety Databases.
  </li>
  <li>
   Implementation of PV agreements and perform the required PV activities related to Patient Data collection systems and Clinical studies.
  </li>
  <li>
   Collaborate closely with the Global Organizations as well as the cross-functional teams (local Management, QA, Medical Affairs, Regulatory Affairs Business Unit)
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Who You Are
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor Degree of Pharmacy or Medicine.
  </li>
  <li>
   Fluent in written and spoken local language and English.
  </li>
  <li>
   4/5 years in PV or in the pharma industry. Health authority experience is an advantage.
  </li>
  <li>
   Understand business needs, think strategically, and develop risk mitigation strategies.
  </li>
  <li>
   High level of dedication and a strong willingness to perform.
  </li>
  <li>
   You are curious, obsessed with customers and patients and act as the owner to make the right decision while keeping in mind the Company&rsquo;s best interests.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What we offer:
 </strong>
 We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 <br/>
 <br/>
 Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
</div>


IQVIA

<div><div><div>New Cairo, Egypt | Full time | Home-based | R1533906</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><br>
Our ever-growing <b>Lifecycle Safety Medical</b> team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.</div><div>
Associate Medical Safety Director</div><div>
Role responsibilities:</div><ul><li><div>
Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product&rsquo;s safety profile</div></li><li><div>
Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate</div></li><li><div>
Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports</div></li><li><div>
Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies</div></li><li><div>
Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up</div></li><li><div>
Providing safety oversight and contribution for label development, review, and updates</div></li><li><div>
Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document</div></li><li><div>
Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams</div></li><li><div>
Representing safety and clinical data review findings during internal and external stakeholder meetings</div></li><li><div>
Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed</div></li></ul><div>
Do you have the skills, experience and qualification required for the role:</div><ul><li><div>
A medical degree from an accredited and internationally recognized medical school</div></li><li><div>
Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience</div></li><li><div>
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process</div></li><li><div>
Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature</div></li><li><div>
Experience in Signal detection, Aggregate reports and Risk management.</div></li><li><div>
Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing</div></li><li><div>
Ability to establish and meet priorities, deadlines, and objectives</div></li><li><div>
Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs</div></li><li><div>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed</div></li></ul><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div></div><div></div>

Associate Medical Safety Director- Sponsor Dedicated

<div><div><div>Istanbul, Turkey | Full time | Home-based | R1533906</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><br>
Our ever-growing <b>Lifecycle Safety Medical</b> team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.</div><div>
Associate Medical Safety Director</div><div>
Role responsibilities:</div><ul><li><div>
Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product&rsquo;s safety profile</div></li><li><div>
Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate</div></li><li><div>
Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports</div></li><li><div>
Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies</div></li><li><div>
Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up</div></li><li><div>
Providing safety oversight and contribution for label development, review, and updates</div></li><li><div>
Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document</div></li><li><div>
Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams</div></li><li><div>
Representing safety and clinical data review findings during internal and external stakeholder meetings</div></li><li><div>
Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed</div></li></ul><div>
Do you have the skills, experience and qualification required for the role:</div><ul><li><div>
A medical degree from an accredited and internationally recognized medical school</div></li><li><div>
Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience</div></li><li><div>
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process</div></li><li><div>
Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature</div></li><li><div>
Experience in Signal detection, Aggregate reports and Risk management.</div></li><li><div>
Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing</div></li><li><div>
Ability to establish and meet priorities, deadlines, and objectives</div></li><li><div>
Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs</div></li><li><div>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed</div></li></ul><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div></div><div></div>

<div>
 Our ever-growing
 <strong>
  Lifecycle Safety Medical
 </strong>
 team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.
 <br/>
 <br/>
 Associate Medical Safety Director
 <br/>
 <br/>
 <strong>
  Role Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product&rsquo;s safety profile
  </li>
  <li>
   Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate
  </li>
  <li>
   Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
  </li>
  <li>
   Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
  </li>
  <li>
   Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up
  </li>
  <li>
   Providing safety oversight and contribution for label development, review, and updates
  </li>
  <li>
   Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
  </li>
  <li>
   Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams
  </li>
  <li>
   Representing safety and clinical data review findings during internal and external stakeholder meetings
  </li>
  <li>
   Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed
   <br/>
   <br/>
  </li>
 </ul>
 Do you have the skills, experience and qualification required for the role:
 <br/>
 <br/>
 <ul>
  <li>
   A medical degree from an accredited and internationally recognized medical school
  </li>
  <li>
   Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
  </li>
  <li>
   Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process
  </li>
  <li>
   Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature
  </li>
  <li>
   Experience in Signal detection, Aggregate reports and Risk management.
  </li>
  <li>
   Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
  </li>
  <li>
   Ability to establish and meet priorities, deadlines, and objectives
  </li>
  <li>
   Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs
  </li>
  <li>
   Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed
   <br/>
   <br/>
  </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 <br/>
 <br/>
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
</div>


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7272 pharmacovigilance specialist jobs Near Me

QPPV Specialist

Patient Safety Center Associate Manager

Regulatory and Pharmacovigilance Senior Expert

Patient Safety Center Associate Manager

Associate Medical Safety Director- Sponsor Dedicated

Associate Medical Safety Director- Sponsor Dedicated

Associate Medical Safety Director- Sponsor Dedicated