Job Description:

Sub-Family Description
Provides medical, scientific, and therapeutic expertise on pharmacovigilance services.
Participates in all aspects of the Medical Safety activities as per scope of work, such as performing medical review
and clarification of trial-related Adverse Events including review of analysis of similar events, medical evaluation of
post-marketing adverse drug reactions, review medical inputs for into signal management and benefit-risk
evaluation of drugs in clinical trial and post marketing set up, safety aggregate report review, safety review of
study protocol, investigators brochure and other reference safety information, clinical study report narrative
review, providing medical assessment comments etc and serving as an internal consultant for any medical support
for pharmacovigilance operations.
JOB OVERVIEW
Job Profile
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 stand-alone safety projects with appropriate oversight from management or more senior
medical safety directors.
Responsibilities
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 c

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