Project Role: Associate Medical Safety Director Work location: Pan India

Work Mode: Home Based

Must Have Skills: Signal Management and Aggregate Reporting.

Education: MBBS or MD is mandatory

Experience : 7+ of PV experience which includes 4+ years of signal and aggregate experience

Job Overview:

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 product’s 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 meeting

~ 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 Report

~ 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 Meeting

~ Attends

📌 Associate Clinical Safety Director (India)
🏢 Iqvia
📍 India