Clinician, Product Safety and Performance

About the role

The Medical Safety Clinician supports medical and scientific functions in safety evaluations for assigned products. You will coordinate post‑market surveillance plans, review aggregate safety data, and assist risk‑management activities across a global, matrixed environment.

Key responsibilities

• Prepare and coordinate Post‑Market Surveillance (PMS) plans, reports, and Periodic Safety Update Reports (PSUR).
• Review and classify data from Clinical Evaluation Reports, literature reviews, and other surveillance sources.
• Manage outsourced data collection and vendor relationships.
• Support physicians with case series review, data analysis, and draft reporting.
• Conduct searches of safety and regulatory databases and collate product quality data.
• 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).
• Experience in medical device or pharmaceutical industry preferred, with up to six years of post‑marketing safety data analysis.
• Familiarity with device safety principles, pharmacology, biostatistics, and epidemiology.
• Ability to work under tight timelines, manage high workload, and thrive in a global matrix environment.

Required skills

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