Bristol Myers Squibb is Hiring Senior Manager, PV System Excellence And Intelligence

• Support quarterly and ad hoc maintenance of key elements of the global BMS Pharmacovigilance System Master File (PSMF).
• Oversee the creation and the maintenance of local market PSMFs as required.
• Support the management of PSMF related projects focusing on data integrity and process enhancement
• 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 (i.e. submission package documentation, late submission Verity tracking etc) as applicable

Position Responsibilities:

• Manage quarterly and ad hoc update of sections/annexes -as assigned- of the global BMS PSMF by initiating workflows notification and overseeing the workflows execution and completion in the electronic PSMF management system
• Support the creation and maintenance of local market PSMFs as required via the electronic PSMF management system
• Support the management of PSMF related projects focusing on data integrity and continuous process enhancement
• 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 (i.e. Verity tracking of late submission(s) as applicable)
• Support users’ first access and ongoing users’ access rights maintenance into the electronic PSMF management system (i.e. sharing settings)
• Support updates to the QPPV Office share point site for PSMF content as required.
• Support PSMF Content Responsible Persons as required
• 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 Pharmacovigilance intelligence activities -as required- according to existing BMS processes
• Maintain the PV intelligence repository as required

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 (e.g. 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.
• 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.
• Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.
• Microsoft Suite
• Other systems as needed