Associate Medical Safety Director
Location: Bengaluru, India
Job ID: R1474799
Employment Type: Full-Time
Job Overview:
As an Associate Medical Safety Director, you will provide expert medical input into pharmacovigilance activities and safety assessments across a range of clinical trials and standalone safety projects. Under the oversight of senior management, you will contribute to trial safety, regulatory reporting, benefit-risk evaluation, and client interactions, ensuring compliance with global safety standards.
Essential Functions:
Conduct medical reviews of AEs and ADRs, including narratives, queries, seriousness, causality, and regulatory assessments
Draft and review AOSEs for expedited safety cases
Serve as a medical advisor to case processing teams on assigned projects
Review safety data (clinical, post-marketing) to maintain product safety profiles
Provide medical coding review for AEs, PMH, and concomitant medications
Present safety findings in client meetings and safety review boards
Contribute to regulatory safety reports: IND Annual Reports, PBRERs, DSURs, US Periodic Reports
Review and edit Risk Management Plans (EU RMP, US REMS) and drug labels
Participate in Safety Monitoring Committees and DSMB meetings
Provide input for Integrated Safety Summaries (ISS) and CTDs
Contribute to benefit-risk assessments and drug safety evaluations
Review and sign off on Project Safety Plans and Medical Monitoring Plans
Evaluate protocols, IDBs, and CRFs for safety content and data accuracy
Act as Global Safety Physician or designated support on assigned projects
Participate in internal, cross-functional, and client-facing project meetings
Ensure timely delivery of all medical safety outputs within regulatory timelines
Offer medical escalation support for MI and EU QPPV projects
Provide 24-hour on-call support for assigned studies as required
Stay updated on global regulatory developments in pharmacovigilance
Qualifications:
Education: Medical degree from an accredited and recognized international medical school – Required
Experience:
Minimum 3 years clinical practice (including graduate medical training) – Required
At least 2 additional years in the pharmaceutical or related industry – Required
Knowledge & Skills:
Strong understanding of global clinical research regulations and GCP
Familiarity with the end-to-end pharmaceutical research and safety processes
Capable of setting priorities, meeting deadlines, and working independently
Effective communication and consultation skills across assignments
Collaborative approach to working with diverse stakeholders
Valid medical license – Preferred
About IQVIA:
IQVIA is a global leader in healthcare intelligence, providing advanced analytics, technology solutions, and clinical research services. Our mission is to help life sciences companies accelerate innovation and improve patient outcomes. Discover more at IQVIA Careers.
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