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

About the role

Alphanumeric Systems is seeking a Medical Director to lead Clinical Safety and Pharmacovigilance activities for a major global pharmaceutical client. The role will provide medical leadership for safety evaluation, benefit‑risk assessment, and risk management across clinical development and post‑marketing phases. The position is remote, based in India, and operates on a 1‑year contract with possible extension.

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.
• Strong understanding of benefit‑risk assessment and safety evaluation.
• Experience supporting regulatory submissions and authority interactions.
• Excellent scientific writing and communication skills.
• Proficiency in English.
• Ability to work independently in a fast‑paced, highly matrixed environment.

Required skills

• Pharmacovigilance
• Regulatory submissions
• Health Authority RFI response
• Benefit‑risk assessment
• Clinical safety data analysis