Position Summary

The Medical Safety Clinician assists and supports the medical and scientific functions within safety evaluations for assigned products. The role includes preparation and coordination of Post Market Surveillance plans and reports, reviewing aggregate safety data, and supporting Risk Management activities by coordinating acquisition and preparation of data for Health Hazard Evaluations.

Duties & Responsibilities

• Review and classify data collected for Clinical Evaluation Reports, literature reviews, and other surveillance activities.
• Manage outsourced data collection and organize preparation with vendors as required.
• Support physicians with case series reviews, data reviews, and draft reports.
• Assist in organizing or running searches of safety or regulatory databases.
• Provide support for PMS activities such as Periodic Safety Update Reports (PSUR) and collate reports for product quality data reviews. ...