.Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Global Medical Safety Lead At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital, and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Purpose of the Function: 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 argenx products Roles and 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