Associate Medical Safety Director – Pharmacovigilance
Location: Kochi, India
Job Type: Full-Time
Work Mode: On-site (additional locations available)
Job Summary:
IQVIA is hiring an experienced Associate Medical Safety Director to lead critical pharmacovigilance activities including medical review of safety data, regulatory submissions, and benefit-risk assessments. This role plays a central part in ensuring drug safety oversight across global clinical trials and post-marketing safety services. Ideal for licensed physicians with a strong foundation in clinical practice and drug safety.
Key Responsibilities:
Perform medical review and clarification of trial-related adverse events (AEs) and ADRs
Review and edit Analyses of Similar Events (AOSE) in compliance with regulatory timelines
Consult pharmacovigilance case processing teams on safety-related issues
Conduct aggregate safety data reviews and oversee product safety profiles
Review clinical data (AEs, medical history, medications) for medical accuracy and coding
Participate in client meetings and safety review discussions
Provide medical input into IND annual reports, PBRERs, PSURs, and DSURs
Contribute to Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS)
Attend DSMB and SMC meetings, offering medical safety evaluation
Support label development and safety updates for regulatory submissions
Perform safety reviews of protocols, CRFs, and IBs for safety data capture
Serve as global safety physician or backup for assigned projects
Ensure timely medical safety deliverables per project requirements
Stay informed about evolving pharmacovigilance regulations and best practices
Required Skills & Qualifications:
Medical degree from an accredited medical school
Minimum 3 years of clinical practice and 2 years of pharma/industry experience (or equivalent)
Strong knowledge of ICH-GCP, PV regulations, and clinical trial processes
Experience with case processing, safety signal detection, and regulatory documentation
Effective communication and medical writing skills
Valid medical license preferred
Ability to manage multiple projects and regulatory timelines
Strong collaboration and consultation skills across global teams
Perks & Benefits:
Global exposure to pharmacovigilance operations
Opportunity to contribute to drug safety on a large scale
Access to cutting-edge clinical research platforms
Collaborative environment with industry leaders
Career advancement opportunities in medical safety
Company Overview:
IQVIA is a global leader in clinical research, healthcare analytics, and pharmacovigilance services. With a mission to accelerate the development of innovative medical solutions, IQVIA connects data, technology, and human expertise to transform healthcare outcomes.
Work Mode:
On-site – Kochi, India (with availability in additional locations)
Call-to-Action:
Are you a licensed physician ready to drive global drug safety? Apply now to lead pharmacovigilance excellence as an Associate Medical Safety Director with IQVIA.
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