Medical Director – SERM Safety & Pharmacovigilance (Remote, Philippines)

About the role

Alphanumeric is hiring a Medical Director to lead Safety Evaluation & Risk Management (SERM) for a global pharmaceutical company. The role provides medical leadership for safety evaluation, benefit‑risk assessment and risk management of products in clinical development and post‑marketing.

Key responsibilities

• Lead safety evaluation and benefit‑risk assessments for assigned products.
• Support pharmacovigilance and risk‑management activities across clinical development and marketed products.
• Contribute to regulatory submissions and health‑authority interactions.
• Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs).
• Analyze and interpret clinical and safety data to support regulatory and business decisions.
• Participate in cross‑functional safety governance and product safety discussions.
• Provide protocol and regulatory support throughout the development lifecycle.
• Escalate significant safety concerns and emerging risks when appropriate.

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; proficiency in English.
• Ability to work independently in a fast‑paced, highly matrixed environment.