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Medical Safety Lead
Location
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Posted
17 days ago
Salary
0
Seniority
Lead
Job Description
Medical Safety Lead
Thermo Fisher Scientific
Title: Medical Safety Lead (client-dedicated), EMEA Location: Remote EMEA Full time The Medical Safety Lead is going to lead and perform the assessment of medical safety data for assigned products, develop and execute safety signaling and benefit-risk management strategies, closely collaborate with stakeholders internally (e.g. Regulatory Affairs, clinical development, medical affairs) and externally (e.g. Key Opinion Leaders or regulatory agencies) to align safety communications and to ensure the safe use of client`s products. A day in the Life: - 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 Keys to Success: - Strong scientific and analytic skills - Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment - Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams - Excellent presentation skills with the ability to communicate complex issues clearly Education and Experience: MD required. History of an active medical license highly preferred. Candidates should have: - 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). Knowledge, Skills and Abilities: - Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents - Demonstrated ability to perform medical assessments of safety data from multiple sources - Experience with authoring complex documents and contributing to regulatory submissions - Knowledge of adverse event reporting systems - Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus
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