Job Title: Senior Medical Safety Advisor
Education Qualification: MBBS/MD.
Work Location: Anywhere in India.
Work Mode: Home Based.
Years of exp: 3yrs Clinical and 2+ yrs of PV (Exp in Oncology is a must)
Pls note MCI reg is mandatory for all the foreign medical graduates.
Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors.
Essential Functions
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements




- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile
- Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Represent safety and clinical data review findings during client meetings
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
- Provide medical oversight for label development, review and change
- Provide medical support and attendance at Data Safety Monitoring Board Meetings • Attends and contributes medical safety evaluation on

📌 Senior Medical Safety Advisor (India)
🏢 Iqvia
📍 India