Medical Director – SERM, Clinical Safety, Pharmacovigilance

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee safety evaluations and benefit-risk assessments for designated products.

• Assist with pharmacovigilance and risk management efforts throughout clinical development and for marketed products.

• Contribute to regulatory submissions and engage with health authorities.

• Prepare and evaluate scientifically robust responses to Health Authority Requests for Information (RFIs).

• Analyze and interpret clinical and safety data to inform regulatory and business decisions.

• Engage in cross-functional safety governance and discussions regarding product safety.

• Provide protocol and regulatory guidance throughout the development lifecycle.

• Raise significant safety concerns and emerging risks as necessary.

• Offer medical leadership for safety evaluations, benefit-risk assessments, and risk management of products during clinical development and post-marketing phases.

⛳️ Requirements

• MD or equivalent medical qualification.

• Extensive experience in clinical development, drug safety, pharmacovigilance, or similar pharmaceutical roles.

• Proven experience in responding to Health Authority Requests for Information (RFIs).

• Strong knowledge of benefit-risk assessment and safety evaluations.

• Experience in supporting regulatory submissions and interactions with regulatory authorities.

• Exceptional scientific writing and communication abilities.

• Proficiency in English is essential.

• Capability to work independently in a dynamic, highly matrixed environment.

• Oncology experience is highly preferred but not mandatory.

• Familiarity with interactions involving FDA, EMA, PMDA, and other global regulatory bodies.

• Experience in supporting global development initiatives.

🏝️ Benefits

• Potential for contract extension.

• Option for remote work arrangements.

• Flexibility to work within U.S. and/or U.K. business time zones.