Senior Medical Safety Advisor (Job ID: R1471135)
Job Description
Company: IQVIA Inc.
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Experience: At least 3 years of clinical practice post-MBBS plus pharmacovigilance/pharma experience (2+ years pharma preferred)
Education: Medical degree (MBBS or equivalent) from an accredited medical school; valid medical license preferred
Expected Salary: ₹18,00,000 – ₹35,00,000 lakhs per year
Job Category: Healthcare, Drug Safety, Medical Affairs
Website: Website
Contact: Contact us
About the Company:
🌍 IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for life sciences and healthcare industries.
The company uses advanced analytics, technology, and domain expertise to accelerate development and commercialization of innovative medical treatments and improve patient and population health worldwide.
About the Role:
🩺 The Senior Medical Safety Advisor provides expert medical evaluation of safety data across clinical trials and post-marketing settings as part of the pharmacovigilance process.You will assess serious adverse events, contribute to aggregate safety reports (e.g., DSUR, RMP, PBRER), lead signal surveillance for assigned products, and act as a senior technical leader within cross-functional safety teams.
Key Responsibilities:
- 📋 Perform medical review of trial AEs and post-marketing ADRs, including narratives, queries, coding, expectedness, seriousness, causality, and company summaries.
- 📑 Compose and medically review Analyses of Similar Events (AOSE) and review safety sections of protocols, IBs, CRFs, and project safety/medical monitoring plans.
- 📊 Conduct aggregate safety reviews (clinical data, post-marketing, literature, observational studies) and support DSURs, RMPs, PBRERs, and ad hoc regulatory reports.
- 🤝 Serve as internal consultant to PV case processing teams; lead and guide safety team members in single case assessment and safety operations.
- 🧩 Maintain watch lists, RSI/labeling lists, support signal detection, audits, training, product transitions, and provide 24-hour medical support and escalation as needed.
Requirements:
- 🎓 Medical degree with at least 3 years of clinical practice; residency/graduate training can count toward experience.
- 💊 Solid knowledge of medicine, GCP, ICH guidelines, pharmacovigilance (ICSR & aggregate reports), and safety regulations.
- 🛠️ Experience using multiple safety databases and strong MS Word, Excel, PowerPoint skills.
- 💬 Strong written and verbal communication, with ability to work effectively with managers, co‑workers, sites, clients, and regulators.
- 📚 In-depth understanding of SOPs, safety processes, and ability to function as lead safety physician and mentor within teams.
Why Join IQVIA?
✅ Influence global drug safety and benefit-risk evaluation for innovative therapies.
✅ Work in a scientifically rigorous, cross-functional environment with strong growth in pharmacovigilance careers.
✅ Competitive senior-level compensation aligned with specialized drug safety expertise.
