Medical Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

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

• Contribute to regulatory submissions and engage with health authorities.

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

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

• Take part in cross-functional safety governance and product safety discussions.

• Provide protocol and regulatory assistance during the development lifecycle.

• Elevate significant safety issues and emerging risks when necessary.

• Aid a global pharmaceutical organization's Safety Evaluation & Risk Management function.

⛳️ Requirements

• MD or an equivalent medical qualification.

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

• Proven experience in responding to Health Authority RFIs.

• Strong grasp of benefit-risk assessments and safety evaluations.

• Background 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.

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

🏝️ Benefits

• Comprehensive benefits.

• Possibility of contract extension.

• Fully remote work opportunity.