Senior Manager, Global PV System Excellence & QPPV Support

Position Summary

The Patient Safety group is responsible for ensuring the safety of our medicines: The Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. The QPPV support team is headed by the QPPV (EEA & UK QPPV) and is an expert interface for regulatory and scientific requirements and build the interface between Local/Regional safety regulatory environment and Global product Teams, both in development and post-marketing. The QPPV team contributes & appropriately review EU RMPs, PSURs/PBRERs, PASS & other PV documents, engages/coordinates PRAC activities and participates in Scientific Advice and similar forums. The Senior Manager, Global PV System Excellence & QPPV support Patient Safety role will support the organization by:

• Manage safety actions screening process of Health Authority website for Countries where BMS is acting as Marketing Authorization Holder
• Support Safety Aggregate reports Health Authorities submission activities (i. e. submission package documentation, late submission Verity tracking etc) as applicable
• Liaise on matters related to (CAP) PSUR preparation and communication
• Coordination role of CAP PSUR submissions as necessary (GSM/BP/HQ/LM)
• Distribution of the IMPD information (Investigational Medicinal Product Dossier) to PV personnel of the concerned EEA Local Markets
• Collaborate to projects involving PS organization for continuous improvements
• QPPV analytics data generation support
• Support for the management of PV-Summary Module 1. 8. 1. ( QPPV Statement ) in terms of preparation, provision and archiving
• Support for maintenance and execution of Nomination letter template on behalf of the QPPV team

Duties/Responsibilities

• Screen Health Authorities websites for notices of Safety Actions pertaining to BMS authorised products ( active substances ) for US, the EEA and applicable countries, document the screening and escalate any identified safety actions as per existing BMS process
• Support coordination of 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 (i. e. Verity tracking of late submission(s) as applicable)
• Back up support coordination of:o MRP and NAP PSUR/PBRERs in liaison with vendor as applicableo Planning responsibilities for EU Reference Date List updateo PRAC recommendations for established brand productso Responses to the EMA (PSUR Repository) regarding assessment reports for established brand PSURs/PBRERs and liaison with vendor as applicable
• Back up support for the management of PV-Summary Module 1. 8. 1. ( QPPV Statement ) in terms of preparation, provision and archiving
• Back up support for maintenance and execution of Nomination letter template on behalf of the QPPV team
• Collaborate to the generation of Analytics data for QPPV oversight: i.e. Safety Variations, QPPV Notifications
• Partner with PS and external PS stakeholders to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the Patient Safety organization

Qualifications

• University degree (preferably health or life science) or nursing qualification
• 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 (e. g. Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment.
• 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.
• Solves complex problems by reviewing data flows and leveraging digital tools and methods.
• Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows.
• Microsoft Suite
• Other systems as needed