Senior Manager, Global PV System Excellence & QPPV Support
Role Overview
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
Full Job Posting
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 [email protected]. 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 [email protected] 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
About Bristol Myers Squibb
Transforming patients' lives through science.
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