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

About the role

Alphanumeric Systems is hiring a SERM Medical Director on a 1‑year remote contract to support a global pharmaceutical organization’s Safety Evaluation & Risk Management function. The role provides medical leadership for safety evaluation, benefit‑risk assessment, and risk management of products in both clinical development and post‑marketing settings.

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, preparing scientifically sound responses to RFIs.
• Analyze and interpret 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 throughout the development lifecycle and escalate significant safety concerns.

Required profile

• MD or equivalent physician qualification.
• Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
• Experience responding to Health Authority Requests for Information (RFIs).
• Strong understanding of benefit‑risk assessment and safety evaluation.
• Experience supporting regulatory submissions and interactions with agencies such as FDA, EMA, PMDA.
• Excellent scientific writing and communication skills.
• Proficiency in English.
• Ability to work independently in a fast‑paced, highly matrixed environment.