Medical Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Provide medical leadership for the assessment of safety, benefit-risk evaluation, and risk management of products in both clinical development and post-marketing environments.

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

• Assist in pharmacovigilance and risk management efforts across clinical and marketed products.

• Contribute to regulatory submissions and interactions with health authorities.

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

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

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

• Provide protocol and regulatory assistance throughout the development lifecycle.

• Raise significant safety concerns and emerging risks when necessary.

⛳️ Requirements

• MD or an equivalent medical qualification.

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

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

• Strong comprehension of benefit-risk assessment and safety evaluation processes.

• Experience in supporting regulatory submissions and interacting 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.

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

• Background in supporting global development programs.

• Willingness to operate within U.S. and/or U.K. business time zones.

🏝️ Benefits

• Potential for contract extension.

• Opportunity for remote work.

• Full-time contract for one year.