Job Description

Should be pulled from the appropriate data in Workday, appropriate source per department, or a contractor agreement. Several top-line sentences in plain text, focused on key accountabilities or duties. Ideally no more than 75 words. Avoid internal jargon or acronyms. Support quarterly and ad hoc maintenance of key elements of the European (EU) BMS Pharmacovigilance System Master File (PSMF). Support quality activities relating to EU PSMF process and maintenance. Help the creation of local market PSMFs as required. Manage safety actions screening process of Health Authority website for Countries where BMS is acting as Marketing Authorization Holder Support Pharmacovigilance intelligence related activities Support Safety Aggregate reports Health Authorities submission activities (ie submission package documentation, late submission Verity tracking etc) as applicable Position Responsibilities Should be pulled from the appropriate data in Workday, appropriate source per department or a contractor agreement. Typically 5-9 bullet points; each describing a distinct and primary responsibility of the role. Avoid generic comments such as works well with others , etc Manage quarterly and ad hoc update of sections/annexes -as assigned- of the EU BMS PSMF by initiating workflows notification and overseeing the workflows execution and completion in the electronic PSMF management system Support generation of quality metrics relating to PSMF update process via the electronic PSMF management system Support the creation of local market PSMFs as required via the electronic PSMF management system Manage users first access and ongoing users access rights maintenance into the electronic PSMF management system (ie sharing settings) Screen Health Authorities websites for notices of Safety Actions pertaining to BMS authorised products ( ) for US, the EEA and applicable countries, document the screening and escalate any identified safety actions as per existing BMS process Support Pharmacovigilance intelligence activities -as required- according to existing BMS processes Maintain the PV intelligence repository as required Prepare submission package documentation for Centrally Authorized Products (CAP) and non-CAP products Safety Aggregate reports in the EEA and manage related documentation activities as applicable (ie Verity tracking of late submission(s) as applicabe) Degree Requirements Required degrees, certifications, and/or licensure relevant to role. University degree (preferably health or life science) or nursing qualification Experience Requirements Minimum number of years of relevant experience expected. At least 5 years in the Pharmaceutical Industry, usually with at least 3-5 years experience of working in Pharmacovigilance or in a closely aligned field (eg Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment. Key Competency Requirements Strong, effective organizational, facilitation, interpersonal and communicating skills with cross-functional stakeholders. Communicate with clarity and consistency to achieve alignment of stakeholders activities. Utilizes effective problem-solving approach to address issues, in a timely manner. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated issues Ability to manage multiple tasks and utilize effective problem-solving approaches and follows up and resolves outstanding issues. Microsoft Suite Other systems as needed

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