Medical Director, SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

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

• Contribute to regulatory submissions and engage with health authorities.

• Prepare 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.

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

• Provide protocol and regulatory assistance throughout the development lifecycle.

• Raise significant safety concerns and emerging risks as necessary.

⛳️ Requirements

• MD or equivalent medical degree.

• 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 evaluations.

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

• Exceptional scientific writing and communication skills.

• Proficiency in English is essential.

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

• Background in oncology is highly desirable but not mandatory.

• Experience liaising with FDA, EMA, PMDA, and other international regulatory bodies.

• Experience in supporting global development initiatives.

🏝️ Benefits

• 1-Year Contract with the possibility of extension.