Associate Medical Director / Safety Physician

About the role

The Associate Medical Director / Safety Physician provides medical safety expertise to sponsors conducting clinical trials and post‑marketing activities for drugs, devices, and combination products. The role involves reviewing adverse events, supporting regulatory reporting, and contributing to client relationships.

Key responsibilities

• Medical review of serious adverse events and adverse events of special interest from clinical trials.
• Prepare and review aggregate safety reports (e.g., PADERs) for global regulatory agencies.
• Support signal detection, evaluation, and preparation of ad‑hoc safety reports.
• Provide safety expertise to project physicians and internal colleagues, including updates on safety regulations.
• Present safety capabilities to clients during proposal activities.
• Develop and enhance client relationships where possible.
• Perform safety activities for spontaneous reports, regulatory authority reports, and medical literature during post‑marketing surveillance.

Required profile

• MD or DO with at least one year of postgraduate training or equivalent.
• Minimum 4 years of experience in pharmaceutical safety, health authority, or CRO settings (or equivalent experience).
• Board‑eligible or board‑certified status preferred, with an accredited residency program.
• Strong knowledge of drug/device safety regulations and global reporting requirements.

Required skills