Associate Medical Safety Director
Location: Bengaluru, India
Job ID: R1497935
Type: Full-Time | Work Mode: Hybrid
Additional Locations: Ahmedabad, India
Job Overview
The Associate Medical Safety Director provides medical expertise in pharmacovigilance and ensures high-quality medical oversight on clinical trials and standalone safety projects. This role involves comprehensive medical review, aggregate safety assessment, and regulatory report contributions, with oversight from senior medical safety leadership. The position serves as a strategic medical resource within the pharmacovigilance function, ensuring compliance with regulatory and scientific standards.
Key Responsibilities
🔹 Medical Review & Case Oversight
Conduct medical review and clarification of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) — including narrative quality, causality, seriousness, coding, and company summary.
Compose, edit, and review Analyses of Similar Events (AOSE) for expedited cases per regulatory requirements.
Provide medical consultation to pharmacovigilance case processing teams on supported projects.
Review and validate coding of AEs, past medical history, and concomitant medications.
🔹 Safety Data Evaluation & Reporting
Perform aggregate safety reviews of clinical and post-marketing data to maintain oversight of product safety profiles.
Contribute medical reviews and edits to:
IND Annual Reports
Periodic Safety Update Reports (PSURs)
Periodic Benefit Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Development Risk Management Plans (RMPs)
US REMS (Risk Evaluation and Mitigation Strategies)
🔹 Clinical & Regulatory Support
Conduct medical safety review of study protocols, Investigator’s Brochures (IBs), and Case Report Forms (CRFs) for safety relevance and data capture adequacy.
Participate in Data Safety Monitoring Board (DSMB) and Safety Monitoring Committee meetings.
Provide medical input into label development, safety summary reports, and benefit-risk assessments.
Review and sign off on Project Safety Plans and Medical Monitoring Plans per contractual scope.
Serve as Global Safety Physician, Assistant, or Back-up as assigned.
Deliver 24-hour medical coverage on assigned projects when required.
🔹 Strategic & Cross-Functional Engagement
Attend client meetings, project safety discussions, and medical team reviews to present clinical safety insights.
Ensure all deliverables meet regulatory or contractual timelines.
Provide medical escalation support for Medical Information and EU Qualified Person for Pharmacovigilance (QPPV) projects.
Stay updated on industry trends, regulatory developments, and evolving medical-safety practices.
Qualifications
Education:
Medical degree (MBBS, MD, or equivalent) from an accredited and internationally recognized institution – Required
Experience:
Minimum 3 years of clinical practice (e.g., post-graduate medical training)
Plus 2 years in the pharmaceutical or related industry (pharmacovigilance, clinical development, or drug safety)
Or an equivalent combination of education, training, and experience
Preferred:
Valid medical license from the practicing country or region
Knowledge & Skills:
Comprehensive understanding of ICH-GCP, FDA, EMA, and other global safety regulations
Strong grasp of clinical trial processes, drug development, and safety surveillance systems
Excellent analytical, consultation, and decision-making skills
Proven ability to prioritize tasks, meet deadlines, and handle multiple complex assignments
Strong interpersonal and communication skills for effective cross-functional collaboration
About IQVIA
IQVIA is a global leader in clinical research, real-world data analytics, and healthcare technology, delivering intelligent connections that accelerate the development and commercialization of innovative therapies. The company partners with life sciences organizations worldwide to improve patient outcomes and population health through science, data, and technology.
🔗 Learn more: https://jobs.iqvia.com
Apply Now
Apply via: IQVIA Careers Portal
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