Senior Pharmacovigilance Scientist

  • Biogen
  • Cambridge, MA, USA
  • Jan 22, 2021

Job Description

Company DescriptionSenior PV Scientist serves as a product lead for Pharmacovigilance activities within Safety or manages PV Scientist(s) or PV Coordinator(s) assigned to products within the Senior PV Scientist's designated products.Job DescriptionThe Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist, along with the Associate Director is responsible for hiring, training, mentoring and managing staff within their assigned products.The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the Sr. PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitatingdecisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.* Leads process for responding to safety questions from regulatory authorities.* Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).* Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.* Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safetyoversight, signal management and responding to ad hoc safety questions.* Direct supervision of PV Scientist(s) and/or PV Coordinators, including hiring, training and mentoring.QualificationsBachelor's Degree in biologic or natural science; or health care discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) requiredMinimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Prior management of direct reports preferred.Additional InformationAll your information will be kept confidential according to EEO guidelines.PDN-9234e4a2-1fd6-4fae-a3cb-cf0bdbf72e0a

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