Associate Medical Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

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

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

• Contribute to regulatory submissions and interactions with health authorities.

• Draft and review 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 discussions regarding product safety.

• Provide protocol and regulatory guidance throughout the entire development lifecycle.

• Recognize and escalate critical safety issues and emerging risks when necessary.

⛳️ Requirements

• MD degree or equivalent physician qualification.

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

• Proven experience in responding to Health Authority RFIs.

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

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

• Exceptional scientific writing and communication abilities.

• Proficiency in English is essential.

• Capacity to work independently in a dynamic, highly matrixed setting.

• Oncology experience is highly preferred but not mandatory.

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

• Experience in supporting global development initiatives.

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

🏝️ Benefits

• Home office reimbursement of up to 50 EUR gross per month.

• Health insurance coverage for the employee.

• Meal allowance in accordance with local labor laws.

• Life insurance coverage.

• Potential for contract extension.