Medical Safety Lead – EMEA

About the role

Thermo Fisher Scientific is seeking a Medical Safety Lead to drive safety assessment and benefit‑risk management for assigned products across the EMEA region. You will work in an office environment, collaborating with cross‑functional teams and external experts to ensure safe product use.

Key responsibilities

• Lead safety signal management, benefit‑risk assessments, and aggregate safety data reviews.
• Coordinate cross‑functional teams to evaluate emerging safety information.
• Develop safety governance structures and contribute to regulatory submission content (ISS, SCS, narratives).
• Prepare and review safety sections of clinical and regulatory documents (protocols, IBs, CSR, ICFs).
• Oversee periodic safety reports (PSUR, DSUR) and ensure consistency and quality.
• Assess individual case safety reports (ICSR) and determine expedited reporting criteria.
• Present safety data to Data Safety Monitoring Boards and support audits/inspections.

Required profile

• Strong background in medical safety, pharmacovigilance, or related clinical science.
• Experience working with regulatory authorities and preparing safety documentation.
• Proven ability to lead cross‑functional teams and communicate complex safety information.

Required skills

• Pharmacovigilance signal detection and benefit‑risk assessment.
• Regulatory submission preparation (ISS, SCS, PSUR, DSUR).
• Medical assessment of individual case safety reports (ICSR, SUSAR).
• Interaction with Data Safety Monitoring Boards (DSMB) and external key opinion leaders.

What we offer

• Opportunity to impact global health outcomes.
• Collaborative environment with access to cutting‑edge clinical research resources.
• Career development support within a leading life‑science organization.