Senior Manager, Medical Safety (Remote)

Brief Description: The Sr. Manager, Medical Safety is a key member of the Medical Safety team within the Global Drug Safety & Pharmacovigilance department. In close collaboration with Medical Safety Physician(s), responsibilities include signal management/clinical surveillance activities, production of aggregate safety reports (eg., PBRERs, DSURs, PADERs), provision of high-level scientific expertise in the safety evaluation and risk management of assigned products, and representation of Medical Safety within the company (eg., leading Safety Management Team). Essential Functions/Responsibilities Leads the coordination of aggregate safety reports (eg., PBRERs, DSURs, PADERs) and authors relevant safety sections. In conjunction with Medical Safety Physician, drives signal management/clinical surveillance process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. In collaboration with Safety Physician, produces accurate and fit for purpose Signal Evaluation Reports or equivalent safety assessment reviews with clear analyses and conclusions. Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, if required. Represents Medical Safety within the company (eg., leading Safety Management Team, participating on other cross-functional teams). In conjunction with Safety Physician, authors and/or guides project teams on the production of risk management plans. In conjunction with Safety Physician, provides strategic input into regulatory requests related to safety. In conjunction with Safety Physician, provides PV contributions to global regulatory submissions for new products, formulations, or indications. May provide safety input into creation or review of Safety Data Exchange Agreements. May serve as business process owner for relevant procedural documents and contribute to process improvement initiatives. Participates in internal audits and Health Authority inspections, as required. Required Knowledge, Skills, and Abilities Minimum Requirements At least 5 years of experience in PV, including at least 3 years of experience in surveillance and/or risk management PV functions. Advanced knowledge of PV regulations regarding aggregate safety reports, signal management, and risk management. Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. In-depth knowledge of medical and drug terminology, as well as the clinical development process. Familiarity with MedDRA and safety databases. Proficiency with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline or experience.

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