🏷️ Job Title:
Senior Medical Safety Advisor
Job ID: R1497941
Location: Bengaluru, India (Hybrid)
Employment Type: Full-time
Job Available in Additional Locations
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🧭 Job Overview
This role provides medical expertise in evaluating safety data from diverse sources within the pharmacovigilance process. The Senior Medical Safety Advisor assesses the medical and scientific relevance of serious adverse event (SAE) reports, placing them in the context of the product’s safety profile and therapeutic area. This role also serves as a senior technical leader, contributing to cross-functional activities, aggregate report preparation, and ongoing safety surveillance for selected products.
🔍 Key Responsibilities
🔎 Medical & Scientific Evaluation
Perform medical review and clarification of:
Trial-related Adverse Events (AEs)
Post-marketing Adverse Drug Reactions (ADRs)
Evaluate:
Narrative content
Clinical queries
Medical coding
Expectedness, seriousness, and causality
Company’s medical summaries
🧪 Safety Surveillance & Reporting
Participate in aggregate safety data reviews and signal detection activities.
Support preparation and medical review of:
Aggregate safety reports
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
Other regulatory submissions
Collaborate with Post-Marketing Safety Experts and the Safety Surveillance Group to ensure ongoing product safety surveillance.
🧠 Subject Matter Expertise
Serve as a senior medical and scientific expert within pharmacovigilance.
Provide input into product safety strategy and risk management plans.
Interpret complex clinical data and determine potential safety implications.
🤝 Cross-functional Collaboration
Work closely with:
Regulatory affairs
Clinical development teams
Safety scientists
Data management
Signal detection and risk management teams
Provide support during inspections, audits, and regulatory authority interactions.
📚 Qualifications
Education:
MD, MBBS, or equivalent degree in medicine required. Specialization in pharmacovigilance, clinical pharmacology, or a relevant therapeutic area is a plus.
Experience:
Significant experience in pharmacovigilance, clinical research, or drug safety.
Experience in medical evaluation of AEs/ADRs and aggregate reporting.
Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA).
🧠 Key Skills & Competencies
Strong clinical judgment and ability to evaluate medical safety information.
Proficiency in narrative writing, case evaluation, and risk assessment.
Knowledge of drug development lifecycle and pharmacovigilance operations.
Strong written and verbal communication skills.
Attention to detail, analytical thinking, and problem-solving abilities.
Ability to work independently and in a cross-functional global environment.
Familiarity with medical coding systems (MedDRA, WHO-ART) and safety databases.
🏢 About IQVIA
IQVIA is a global leader in clinical research, healthcare analytics, and real-world evidence generation. Through advanced data, technology, and insights, we help bring innovative therapies to market and improve health outcomes worldwide.
🔗 Learn more: https://jobs.iqvia.com
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