Medical Safety Lead (client-dedicated), EMEA

The Medical Safety Lead at Thermo Fisher Scientific is responsible for leading and performing medical safety data assessments for assigned products, developing safety strategies, and collaborating with internal and external stakeholders to ensure the safe use of products. The role involves strategic leadership, safety signal management, regulatory document preparation, and safety reporting.

Location: Office (unspecified city/country)

Responsibilities

• Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
• Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)
• Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
• Contribute to the development of the overall safety governance structure and activities
• Provide safety strategies and deliver accurate, timely and high-quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
• Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
• Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
• Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
• Oversee the medical assessment of individual case safety reports (ICSR)
• Confirm criteria and content for expedited reporting and unbinding (e.g. SUSAR or urgent safety issues)
• Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
• Provide medical safety contributions at internal audits and regulatory inspections
• Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
• Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
• Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners
• Participate in cross-functional teams and initiatives

Requirements

• MD required
• History of an active medical license highly preferred
• Clinical experience in having direct responsibility for diagnostic and treatment decisions (2+ years)
• Direct experience in medical review and assessment of safety information/Pharmacovigilance (5+ years)

Additional Information

• The role is based in an office environment with a standard Monday to Friday schedule.
• The position requires strong scientific and analytical skills, leadership, collaboration, and excellent communication skills.
• Knowledge of pharmacovigilance regulatory requirements, safety data assessment, and experience with regulatory documents are essential.
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.
• Thermo Fisher Scientific values diversity and is an equal opportunity employer.