Medical Director (SERM & Clinical Safety & Pharmacovigilance) - Remote - Based in India at Alphanumeric Systems in India, IN

Job description

• Alphanumeric is hiring a SERM Medical Director (Remote, 1-Year Contract) to work for one of the biggest pharmaceutical companies in the world.
• We are looking for a SERM Medical Director to support a global pharmaceutical organization's Safety Evaluation & Risk Management function. This role will provide medical leadership for the safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings.
• The ideal candidate will combine strong clinical development and pharmacovigilance expertise with the ability to independently assess safety issues, support regulatory interactions, and contribute to cross-functional decision-making.

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.

Requirements

• 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 regulatory authority interactions.
• Excellent scientific writing and communication skills. Proficiency in English is mandatory.
• Ability to work independently in a fast-paced, highly matrixed environment.
• Oncology experience is highly desirable but not required.
• Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
• Experience supporting global development programs.

Skills

Required

• MD or equivalent physician qualification
• Proficiency in English is mandatory

Preferred

• Oncology experience