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Assoc Dir, Medical Safety

3+ years
Not Disclosed
10 July 8, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.