Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionGlobal Medical Safety leadPurpose 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. 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
Skills and Competencies:
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
Relevant computer skills, including proficiency with Microsoft Office
Education, Experience and Qualifications:
MD degree or equivalent required
At least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
At least 1 year of experience in clinical practice or in academic medicine
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
