Associate Medical Safety Director
Kochi, India
(Also available in additional locations)
Full-Time | Onsite/Hybrid
Job ID: R1479136
As an Associate Medical Safety Director, you will provide high-level medical expertise across pharmacovigilance services and safety-related clinical trials. This role supports medical safety operations across assigned trials and standalone safety projects, with oversight from senior leadership.
Conduct medical review and clarification of:
Clinical trial-related Adverse Events (AEs)
Post-marketing Adverse Drug Reactions (ADRs)
Evaluate case narratives, causality, seriousness, expectedness, and coding (e.g., MedDRA)
Compose and review Analyses of Similar Events (AOSE) for expedited regulatory reporting
Serve as internal consultant to pharmacovigilance case processing teams
Represent Medical Safety findings in client meetings
Provide medical review of:
Project Safety Plans
Medical Monitoring Plans
Protocols
Case Report Forms (CRFs)
Investigational Drug Brochures (IDBs)
Conduct safety profile oversight using:
Clinical trial data
Post-marketing surveillance
Literature reviews
Contribute medical content for:
Annual Safety Reports (e.g., IND, DSUR, PBRER, PSUR, DSUR, etc.)
Risk Management Plans (RMPs)
Risk Evaluation and Mitigation Strategies (REMS)
Integrated Safety Summaries (ISS)
Common Technical Documents (CTDs)
Drug Safety Reports and Benefit-Risk Assessments
Act as Global Safety Physician or assistant/back-up as assigned
Support:
Medical Information escalations
EU Qualified Persons for Pharmacovigilance (QPPV)
Data Safety Monitoring Boards (DSMBs) and Safety Monitoring Committees
Provide 24-hour medical coverage for assigned studies when required
Stay updated on evolving medical safety regulatory requirements
| Criteria | Details |
|---|---|
| Education | Medical degree from an internationally recognized medical school (Required) |
| Clinical Experience | At least 3 years of clinical practice (e.g., residency or graduate medical training) |
| Pharma Experience | Minimum 2 years in pharmaceutical or related industry roles (or equivalent combination of experience and education) |
| Licensure | Valid medical license in country/region of residence (Preferred) |
In-depth knowledge of GCP, ICH, and global pharmacovigilance regulations
Strong understanding of:
Clinical trials
Drug development and safety monitoring processes
Expertise in reviewing clinical data (labs, narratives, coding)
Excellent written and verbal communication skills
Ability to manage multiple priorities, meet deadlines, and handle complex safety reviews
Collaborative, consultative, and detail-oriented approach
Proficient in working with cross-functional teams, clients, and regulatory bodies
IQVIA is a global leader in clinical research, real-world evidence, data analytics, and technology services, enabling smarter healthcare decisions and improving patient outcomes.
🌐 Learn more: https://jobs.iqvia.com
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