Clinician, Product Safety and Performance

About the role

The Medical Safety Clinician will support safety evaluations for assigned products, coordinating post‑market surveillance plans, reviewing aggregate safety data, and assisting risk‑management activities such as health‑hazard evaluations.

Key responsibilities

• Review and classify data from Clinical Evaluation Reports, literature reviews and other surveillance activities.
• Manage outsourced data collection and coordinate with vendors as required.
• Support physicians with case‑series review, data review and draft report preparation.
• Organize and run searches of safety or regulatory databases.
• Assist post‑market surveillance activities, including preparation of Periodic Safety Update Reports (PSUR) and collating product quality data.
• Support health‑hazard evaluations, scientific presentations and related documentation.
• Participate in the preparation, analysis and writing of ad‑hoc and aggregate regulatory reports and labeling support documents.

Required profile

• Advanced academic degree in a health‑care discipline (e.g., MD, DO, ARNP).
• Previous experience in the medical device or pharmaceutical industry; six years of post‑marketing safety data analysis preferred.
• Familiarity with device safety principles, device development, pharmacology, biostatistics and epidemiology.
• Basic knowledge of common data‑processing software.

Required skills

• Functional knowledge of Microsoft Excel.
• Functional knowledge of Microsoft PowerPoint.
• Functional knowledge of Microsoft Word.