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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