Medical Director (SERM & Clinical Safety & Pharmacovigilance) - Remote, India

About the role

Alphanumeric is hiring a SERM Medical Director on a 1-year remote contract, based in India, to support a global pharmaceutical company's Safety Evaluation and Risk Management function. The role provides medical leadership for safety evaluation, benefit-risk assessment and risk management of products in clinical development and post-marketing settings. Candidates should combine clinical development and pharmacovigilance expertise with the ability to assess safety issues independently, support regulatory interactions and contribute to cross-functional decisions. Expertise in classic established products, oncology, respiratory, immunology, inflammation, vaccines and infectious disease is requested.

Key responsibilities

• Lead safety evaluation and benefit-risk assessments for assigned products
• Support pharmacovigilance and risk management across clinical development and marketed products
• Contribute to regulatory submissions and health authority interactions
• Prepare and review 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 is mandatory
• Ability to work independently in a fast-paced, highly matrixed environment
• Availability to work within U.S. and/or U.K. business time zones

Preferred: oncology experience, experience with FDA, EMA, PMDA and other global regulators, and experience supporting global development programs.