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Assoc Dir, Medical Safety

3+ years
Not Disclosed
10 July 16, 2025
Job Description
Job Type: Full Time 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 – Bengaluru (Hybrid)

Location: Bengaluru, India
Job Type: Full-time
Work Mode: Hybrid
Experience Level: Senior (3+ years clinical + 2+ years pharma/CRO)
Salary Range: Not specified


Job Summary

IQVIA is hiring an experienced Associate Director, Medical Safety to lead global pharmacovigilance services in its Bengaluru office. This senior-level role involves oversight of safety strategy, signal evaluation, and regulatory compliance for clinical and post-marketing safety operations. The ideal candidate brings deep clinical expertise, leadership skills, and proficiency in global drug safety regulations. You will also line-manage regional physicians and engage directly with clients, internal stakeholders, and business development functions.


Key Responsibilities

  • Perform expert medical review and clarification of clinical and post-marketing AEs/ADRs.

  • Review narratives, queries, coding, causality, expectedness, and benefit-risk assessments.

  • Oversee AOSEs, DSURs, PSURs, PBRERs, RMPs, and global safety documentation.

  • Participate in and lead Safety Monitoring Committees and DSMBs.

  • Review protocols, IBs, CRFs, and safety plans to ensure regulatory alignment.

  • Lead integrated safety summaries and clinical benefit-risk evaluations.

  • Represent the safety function during client meetings and regulatory interactions.

  • Serve as Global Safety Physician, Assistant, or Back-up as per project needs.

  • Provide medical escalation support and 24-hour medical safety input for assigned studies.

  • Manage and mentor a team of regional safety physicians, ensuring delivery and engagement.

  • Represent the medical safety function in business development and bid defense discussions.

  • Actively participate in cross-functional and SME meetings for continuous service improvement.


Required Skills & Qualifications

  • Medical degree (MBBS, MD, or equivalent) from an accredited institution – Required

  • Minimum 3 years clinical practice + 2 years in pharmaceutical/biotech/CRO – Required

  • Deep understanding of ICH-GCP, GVP, and pharmacovigilance regulatory requirements.

  • Strong leadership, people management, and strategic planning experience.

  • Excellent verbal and written communication, medical writing, and presentation skills.

  • Confident with complex stakeholder engagement and senior-level decision-making.

  • Familiarity with PV safety databases and tools.

  • Valid medical license preferred.


Perks & Benefits

  • Strategic leadership role in global pharmacovigilance

  • Hybrid work flexibility from Bengaluru location

  • Exposure to global regulatory frameworks and high-impact client projects

  • Access to IQVIA’s research platforms, training programs, and industry innovations

  • Opportunities for career progression into global leadership


Company Overview

IQVIA is a global leader in clinical research, pharmacovigilance, and real-world data solutions. Serving top pharma and biotech clients, IQVIA advances healthcare by integrating scientific expertise, technology, and real-time data to enhance patient outcomes and drug safety globally.


Work Mode

Hybrid – The role is based in Bengaluru, with flexibility to collaborate globally.


Call to Action

Looking to take your pharmacovigilance career to the next level? Join IQVIA as Associate Director, Medical Safety and lead drug safety operations that impact global public health. Apply today and make a difference in clinical development and patient safety.