Medical Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

• Assist in pharmacovigilance and risk management initiatives throughout clinical development and for marketed products.

• Play a role in regulatory submissions and engage with health authorities.

• Draft and assess scientifically robust replies to Health Authority Requests for Information (RFIs).

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

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

• Offer protocol and regulatory guidance throughout the development lifecycle.

• Report significant safety issues and emerging risks as necessary.

⛳️ Requirements

• MD or equivalent medical qualification.

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

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

• Strong grasp of benefit-risk assessment and safety evaluation methodologies.

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

• Exceptional scientific writing and communication abilities.

• Proficiency in English is essential.

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

• Experience in oncology is highly desirable but not mandatory.

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

• Experience in supporting global development initiatives.

🏝️ Benefits

• Potential for contract extension.