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

About the role

Alphanumeric is hiring a SERM Medical Director on a 1‑year remote contract to provide medical leadership for safety evaluation, benefit‑risk assessment and risk management of pharmaceutical 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, including preparing responses to RFIs.
• Analyze and interpret clinical and safety data to support regulatory and business decisions.
• Participate in cross‑functional safety governance and product safety discussions.

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.

Preferred profile

• Oncology experience (highly desirable).
• Experience interacting with FDA, EMA, PMDA and other global regulatory agencies.
• Experience supporting global development programs.