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

About the role

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.

Location

Remote, based in India.

Employment Type

Full-Time | 1-Year Contract | Potential Extension

Working Hours

Candidates must be available to work within U.S. and/or U.K. business time zones.

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 Qualifications

• 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.

• Preferred Qualifications

• Oncology experience is highly desirable but not required.

• Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.

• Experience supporting global development programs.