Medical Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

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

• Play a role in regulatory submissions and interactions with health authorities

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

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

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

• Offer protocol and regulatory support throughout the product development lifecycle

• Raise significant safety issues and emerging risks when necessary

⛳️ Requirements

• MD or equivalent medical qualification

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

• Experience in responding to Health Authority Requests for Information (RFIs)

• Strong knowledge of benefit-risk assessments and safety evaluations

• Proven experience 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 setting

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

• Experience in oncology is highly preferred but not mandatory

• Familiarity with interactions involving FDA, EMA, PMDA, and other global regulatory bodies

• Experience in supporting global development initiatives

🏝️ Benefits

• Possibility of contract extension

• Fully remote work / 100% from home