Medical Safety Lead – Client Dedicated (EMEA)

About the role

The Medical Safety Lead will drive the assessment of medical safety data for assigned products across the EMEA region. Working within Thermo Fisher Scientific, you will develop safety signaling and benefit‑risk strategies while collaborating with internal and external stakeholders to ensure safe product use.

Key responsibilities

• Provide strategic medical safety leadership for assigned product(s) in a cross‑functional setting.
• Perform safety signal management, benefit‑risk assessments, and regular aggregate safety data reviews.
• Lead cross‑functional teams to review emerging safety data and contribute to safety governance structures.
• Prepare safety sections for regulatory submissions (ISS, SCS, narratives) and clinical documents (protocols, IBs, CSR, ICFs).
• Support responses to regulatory authority inquiries and ensure timely, complete, and accurate safety information.
• Lead the preparation of periodic safety reports (PSUR, DSUR) and oversee medical assessment of individual case safety reports.
• Confirm criteria for expedited reporting (SUSAR, urgent safety issues) and present safety information to DSMBs.
• Contribute to internal audits, regulatory inspections, and updates to safety standards.

Required profile

• Proven experience in medical safety or pharmacovigilance within the pharmaceutical/clinical research sector.
• Strong understanding of regulatory requirements and benefit‑risk assessment processes.
• Ability to lead cross‑functional teams and communicate safety information effectively.
• Attention to detail and commitment to delivering accurate, high‑quality safety documentation.

Required skills

What we offer

• Opportunity to impact global health outcomes through meaningful safety work.
• Access to resources that support individual career growth.
• Collaboration with leading experts in clinical research and regulatory affairs.