Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Provide scientific leadership in assessing product safety, managing benefit-risk evaluations, and overseeing pharmacovigilance activities throughout clinical development and post-marketing initiatives.

• Lead safety evaluations and risk management efforts for designated products.

• Analyze safety data obtained from clinical trials, post-marketing reports, and scientific literature.

• Assist in global regulatory submissions and interactions with health authorities.

• Compose and review responses to Health Authority Requests for Information (RFIs).

• Offer protocol, safety, and regulatory guidance to clinical development teams.

• Engage in cross-functional safety governance and risk management initiatives.

• Recognize emerging safety issues and propose suitable actions.

• Collaborate with internal stakeholders to develop scientifically sound and compliant safety strategies.

• Manage safety issues independently and contribute to strategic safety decision-making for global programs.

⛳️ Requirements

• An advanced degree in a scientific or healthcare-related field (PhD, PharmD, MS, NP, RN, or equivalent).

• Extensive experience in clinical development, drug safety, pharmacovigilance, or a related discipline.

• Experience in addressing Health Authority Requests for Information (RFIs).

• Strong background in protocol support and regulatory affairs.

• Exceptional analytical, scientific writing, and communication abilities.

• Proficiency in English is essential.

• Capability to work independently while appropriately escalating issues as necessary.

• Proven ability to collaborate effectively within global cross-functional teams.

• Experience in oncology is highly valued but not mandatory.

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

• Experience in supporting global development initiatives.

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

🏝️ Benefits

• 1-Year Contract

• Potential for Extension

• Remote work opportunity based in Portugal