Senior Manager, Global PV System Excellence & QPPV Support

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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. Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.

Microsoft Suite

Other systems as needed

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to  adastaffingsupport@bms.com . Visit  careers.bms.com/eeo-accessibility  to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:  https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at  https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at  TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607166 : Senior Manager, Global PV System Excellence & QPPV Support