Medical Director of Patient Safety

Senior Medical Safety Advisor Job Summary

This position provides medical expertise in evaluating safety data and determining the relevance of serious adverse event reports within the context of a product’s safety profile.

The senior medical safety advisor will lead matrix management activities, including preparing or participating in evaluating safety issues and preparing aggregate reports with post-marketing safety experts and safety surveillance group.

Responsibilities :

• Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
• Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Providing coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
• Serving as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Ensuring service delivery from productivity, compliance, and quality perspectives within regulatory timelines

About This Role

We are seeking a highly skilled Senior Medical Safety Advisor to join our team. As a key member of our organization, you will play a critical role in ensuring the safe use of our products.

In this position, you will be responsible for evaluating safety data and determining the relevance of serious adverse event reports. You will also lead matrix management activities, including preparing or participating in evaluating safety issues and preparing aggregate reports with post-marketing safety experts and safety surveillance group.

What We Offer :