Director, Head of Pharmacovigilance System Master
vor 1 Woche
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines: The Worldwide 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.
Position Summary / Objective
- Lead maintenance of BMS' Pharmacovigilance System Master File (PSMF).
- Ensure continuous oversight of BMS' Pharmacovigilance System and awareness of Pharmacovigilance related activities and topics to ensure seamless continuity of EEA QPPV responsibilities/BMS PV system.
- Involvement in QMS initiatives or projects impacting PSMF
- Global Process Lead (GPL) for PSMF
Position Responsibilities
- Manage PSMF team to ensure ongoing maintenance of BMS' Pharmacovigilance System Master File including the oversight and overall coordination of the local required PSMFs across different markets
- Ensure collaboration with the EEA QPPV and key WWPS stakeholders to ensure continuous oversight of BMS' Pharmacovigilance System and awareness of Pharmacovigilance related activities and topics to ensure seamless continuity of EEA QPPV responsibilities/BMS PV system.
- Represent PSMF office in key forum/projects impacting PSMF
- Involvement in QMS initiatives or projects impacting PSMF
- Lead "PSMF and EV-Operations" team
- EudraVigilance Account Maintenance Oversight /Trusted deputy for Eudravigilance Oversight
- Coordinate the support as PSMF team
- Manage GxP inspections/audits for PSMF related topics and interviews
- Collaborate with PV Compliance and Quality Risk Management function in WWPS in relation to quality standards and metrics for PSMF
- Coordinate training related to PSMF and PSMF esystem maintenance in close partnership with IT Business Partner/Digital Capability Management team
Degree Requirements: - University degree (preferably health or life science)
Experience Requirements
- At least 10 years in the Pharmaceutical Industry, usually with at least 5 years' experience of working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, Quality or Medical Information) within the pharmaceutical industry, medical or Regulatory environment. Experience in people management and preferably with remote management experience too.
Key Competency Requirements
- Demonstrated strong, effective organizational, facilitation, interpersonal and communicating skills with crossfunctional.
- Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding PSMF.
- Utilizes effective decisionmaking and a problemsolving approach to address safety issues, in a timely manner, while balancing the operation and strategic needs. 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 safety issues, while retaining accountability.
- Ability to manage multiple tasks and utilize effective problemsolving approaches and independently follows up and resolves outstanding issues.
- Successful and creative negotiation of difficult safety/compliance issues.
- Ability to manage strategic business changes and to adapt to changing business needs, conditions, and work responsibilities.
- Microsoft Suite
- Other systems as needed
Travel Required
- Travels required in this position, worldwide.
Uniquely Interesting Work, Life-changing Careers
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.-
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