Medical Director (SERM & Clinical Safety & Pharmacovigilance) – Remote – Poland

About the role

Alphanumeric Systems is seeking a Medical Director to lead Safety Evaluation & Risk Management (SERM) for a major global pharmaceutical company. The role is fully remote, based in Poland, and focuses on safety evaluation, benefit‑risk assessment, and risk management across clinical development and post‑marketing phases.

Key responsibilities

• Lead safety evaluation and benefit‑risk assessments for assigned products.
• Support pharmacovigilance and risk‑management activities throughout clinical development and after market launch.
• Contribute to regulatory submissions and interact with health authorities.
• Prepare scientifically sound responses to Health Authority Requests for Information (RFIs).
• Analyze clinical and safety data to inform regulatory and business decisions.
• Participate in cross‑functional safety governance and product safety discussions.
• Provide protocol and regulatory support across the product lifecycle.
• Escalate significant safety concerns and emerging risks as needed.

Required profile

• MD or equivalent physician qualification.
• Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
• Experience responding to Health Authority RFIs and supporting regulatory submissions.
• Strong understanding of benefit‑risk assessment and safety evaluation.
• Excellent scientific writing and communication skills in English.
• Ability to work independently in a fast‑paced, matrixed environment.

Required skills

• Medical degree (MD) or equivalent.
• Proficiency in English.