Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

• Independently address safety issues and play a crucial role in strategic safety decision-making for global programs.

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

• Analyze safety data from clinical trials, post-marketing information, and scientific publications.

• Assist with global regulatory submissions and engage with health authorities.

• Draft 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 processes.

• Detect emerging safety issues and propose appropriate measures.

• Collaborate with internal stakeholders to ensure the implementation of scientifically robust and compliant safety strategies.

⛳️ Requirements

• 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 area.

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

• Strong background in protocol support and regulatory affairs.

• Exceptional analytical, scientific writing, and communication capabilities.

• Proficiency in English is essential.

• Ability to work autonomously and escalate issues appropriately when necessary.

• Experience collaborating effectively within global cross-functional teams.

• Oncology experience is highly preferred but not mandatory.

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

• Experience supporting global development initiatives.

• Availability to work in U.S. and/or U.K. business time zones.

🏝️ Benefits

• 1-Year Contract with Potential Extension