Associate Director, Medical Safety – Pharmacovigilance Leadership Role
Location: Bengaluru, India
Job Type: Full-Time
Work Mode: On-site (Available in additional locations)
Job Summary:
IQVIA is seeking an experienced Associate Director, Medical Safety to lead global pharmacovigilance projects and ensure comprehensive oversight of drug safety operations. This senior-level role involves managing cross-functional safety teams, participating in regulatory safety submissions, and driving medical strategy for clinical development and post-marketing programs. An ideal fit for licensed physicians with strong leadership in PV operations and global health authority interactions.
Key Responsibilities:
Oversee medical review and clarification of AEs and ADRs, including seriousness, causality, coding, and narratives
Review expedited cases and compose Analyses of Similar Events (AOSE)
Serve as safety consultant for PV case processing and regulatory submissions
Conduct aggregate reviews of clinical and safety data to assess benefit-risk
Participate in DSMB, SMC, and medical safety meetings
Contribute to and review regulatory documents: PBRERs, PSURs, DSURs, IND reports
Author/review RMPs, REMS, Integrated Safety Summaries, and CTDs
Oversee development and review of safety protocols, CRFs, and IBs
Line-manage regional medical safety physicians, ensuring operational excellence
Ensure regulatory deliverables are met on-time across assigned studies
Act as Global Safety Physician or back-up as needed on critical programs
Engage in bid defenses, proposal reviews, and strategic client meetings
Provide escalation support for medical information and EU QPPV projects
Lead medical safety representation in internal IQVIA meetings and SME groups
Promote employee engagement, development, and team performance
Required Skills & Qualifications:
Medical degree (MBBS, MD, or equivalent) from an accredited and recognized institution
Minimum 3 years of clinical practice plus 2 years in the pharmaceutical industry
Strong knowledge of pharmacovigilance regulations including GVP, ICH-GCP
Demonstrated leadership in managing medical safety teams
Experience in global regulatory submissions and benefit-risk assessments
Advanced business acumen and project/financial management experience
Excellent communication, negotiation, and stakeholder engagement skills
Valid medical license preferred
Proven ability to manage multiple priorities and lead through influence
Perks & Benefits:
Senior leadership role in a global pharmacovigilance organization
Work on international, multi-center trials with cross-functional teams
Access to cutting-edge safety and clinical technologies
Dynamic, inclusive, and collaborative workplace culture
Career growth and continuous learning in a fast-paced healthcare environment
Company Description:
IQVIA is a global leader in clinical research and healthcare analytics, delivering integrated data science and medical solutions to life sciences clients. With a commitment to transforming patient outcomes, IQVIA empowers pharmaceutical innovation through world-class research and pharmacovigilance services.
Work Mode:
On-site – Based in Bengaluru, India (with roles also available in additional locations)
Call-to-Action:
If you're a licensed physician ready to lead global pharmacovigilance strategy and make a difference in patient safety, apply now to join IQVIA as an Associate Director, Medical Safety.
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