Sr. Scientist, Drug Safety

Job Description

Under the direction of an Associate Principal Scientist/Principal Scientist, the Medical Associate will be responsible for support of activities within Clinical Safety and Risk Management for Devices and Product Quality and as a liaison to partners within company Research Laboratories Device Development, Manufacturing Division, Quality and Compliance, and the Risk Management Safety Team in support of the pipeline and marketed product portfolio throughout the product lifecycle.

Primary Responsibilities

• Monitor, triage and assess requests received in the CSRM DPQ mailbox for Safety Assessments for Quality Investigations.
• Partner with CSRM DPQ Risk Assessment Physician in performing Safety Assessments for Quality Investigations, in the form of a Medical Assessment Memo (MAM) or a Health Hazard Evaluation (HHE) and contribute to implementation of updates to product risk management required as output of Health Risk Assessment.