Medical Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

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

• Contribute to regulatory filings and engage with health authorities

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

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

• Participate in cross-functional safety governance and discussions regarding product safety

• Offer protocol and regulatory guidance throughout the development lifecycle

• Raise significant safety issues and emerging risks as necessary

• Provide medical leadership in safety evaluation, benefit-risk analysis, and risk management for products in both clinical development and post-marketing contexts

⛳️ Requirements

• MD or equivalent medical degree

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

• Experience in addressing Health Authority RFIs

• Strong comprehension of benefit-risk assessment and safety evaluations

• Proven experience in supporting regulatory submissions and interactions with regulatory bodies

• Exceptional scientific writing and communication abilities

• Proficiency in English is essential

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

• Oncology experience is highly desirable, though not mandatory

• Experience engaging with FDA, EMA, PMDA, and other international regulatory agencies

• Background in supporting global development initiatives

🏝️ Benefits

• Home office reimbursement

• Private health insurance

• Base salary