Senior Manager, Medical Safety
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Medical Safety to join our team. About the Role
This role 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 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 Ensures that available safety information is evaluated in order to meet both internal and external requirements Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, if required 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 Benefits
The successful candidate will be eligible to participate in various benefits offerings, including medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Medical Safety to join our team. About the Role
This role 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 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 Ensures that available safety information is evaluated in order to meet both internal and external requirements Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, if required 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 Benefits
The successful candidate will be eligible to participate in various benefits offerings, including medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
