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. The role supports safety monitoring, regulatory reporting, and client relationship development.

Key responsibilities

• Medical review of serious adverse events and adverse events of special interest from clinical trials.
• Preparation and medical review of aggregate reports (e.g., PADERs) for global regulatory agencies.
• Support to project physicians and presentation of safety capabilities to clients.
• Medical review of spontaneous and regulatory adverse event reports during post‑marketing surveillance.
• Signal detection, evaluation, and preparation of ad‑hoc safety reports for regulatory submission.
• Provide safety expertise to internal colleagues and communicate regulatory changes.

Required profile

• MD or DO with at least one year of postgraduate training and substantial knowledge of drug/device safety regulations.
• Minimum 4 years of experience in safety, QA, regulatory affairs, medical writing, or clinical monitoring within a pharmaceutical company, health authority, or CRO.
• Board‑eligible or board‑certified status preferred, with at least 4 years of relevant experience.

Required skills

• Medical safety expertise
• Adverse event review
• Signal detection and evaluation
• Regulatory reporting and aggregate report preparation