🏷️ Job Title:
Associate Medical Safety Director
Job ID: R1474799
Location: Kochi, India (Additional locations available)
Employment Type: Full-Time
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🧭 Job Overview
The Associate Medical Safety Director provides medical expertise in pharmacovigilance services, participating in clinical trial and post-marketing safety evaluations. The role includes responsibilities across medical review, regulatory documentation, risk-benefit assessment, and safety oversight for standalone safety projects and clinical trials, under appropriate supervision from senior leaders.
🔍 Key Responsibilities
📝 Medical Review & Safety Evaluation
Conduct medical review and clarification of:
Trial-related Adverse Events (AEs)
Post-marketing Adverse Drug Reactions (ADRs)
Narrative content, seriousness, causality, expectedness, and company summaries
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases
📊 Aggregate & Regulatory Reporting
Perform aggregate safety data reviews (clinical and post-marketing)
Provide medical review and edits for:
IND Annual Reports
EU PBRER, PSUR, DSUR
US Periodic Reports
Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
Contribute to:
Integrated Safety Summaries
Common Technical Documents (CTDs)
Drug Safety Reports and other benefit-risk assessments
🛡️ Product Safety & Oversight
Oversee:
Label development, review, and changes
Safety content in Protocols, Investigator Drug Brochures (IDBs), and Case Report Forms (CRFs)
Serve as:
Global Safety Physician or Assistant/Back-up on assigned projects
Medical representative at Data Safety Monitoring Board (DSMB) and Safety Monitoring Committees
👥 Collaboration & Communication
Attend and contribute to:
Internal medical safety team meetings
Client meetings and project discussions
Review and sign off on:
Project Safety Plans
Medical Monitoring Plans
Support:
Medical Information Projects
EU QPPV Projects (Qualified Person for Pharmacovigilance)
⏱️ Operational Accountability
Ensure coverage for all medical safety deliverables within regulatory and contract timelines
Provide 24/7 medical support for assigned projects
Stay informed about evolving medical, regulatory, and safety guidelines
🎓 Qualifications
📚 Education
Medical Degree from an accredited and internationally recognized medical school (Required)
Valid Medical License in country/region of residence (Preferred)
💼 Experience
3 years of clinical practice experience (e.g., graduate medical training)
2 years of experience in the pharmaceutical or related industry in any role
OR equivalent combination of education, training, and industry experience
💡 Knowledge & Skills
In-depth knowledge of:
Clinical trials and the pharmaceutical development process
Global and local regulatory requirements (e.g., GCP, ICH)
Safety reporting systems and practices
Ability to:
Prioritize and meet deadlines
Provide expert consultation across multiple projects
Build and maintain professional relationships with internal and external stakeholders
🏢 About IQVIA
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help healthcare and life sciences clients drive innovation and improve outcomes.
🌐 Learn more: https://jobs.iqvia.com
📩 Interested?
Click here to apply now
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