Manager - Pharmacovigilance System Master File and Pharmacovigilance Intelligence

Manager, PSMF office & PV Intelligence

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. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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 Safety Quality Management (SQM) organization supports shaping tomorrow's healthcare landscape through forward-thinking third party and internal compliance, transformative quality & procedural initiatives, PSMF excellence, facilitating engagement with PV Regulatory Intelligence, and dynamic external collaborations.

Duties/Responsibilities

• Oversee ongoing maintenance of designated Sections and Annexes within the BMS Pharmacovigilance System Master File (PSMF).
• Collaborate with the Head of PSMF, EEA QPPV, and key pharmacovigilance stakeholders to ensure consistent oversight of the BMS Pharmacovigilance System, supporting EEA QPPV responsibilities and PV activities.
• Support continuous improvement initiatives for the PSMF Content Management System, focusing on data quality and operational efficiency.
• Assist in the creation of local market PSMFs as required.
• Coordinate onboarding, user training, and access management for the PSMF Content Management System.
• Contribute to the implementation of Veeva Vault enhancements in partnership with IT.
• Support pharmacovigilance intelligence activities in line with BMS procedures, including organization of related activities, coordination of internal assessments (outside the PEARL process), and monitoring PV intelligence performance within the company’s electronic repository.
• Maintain the PV intelligence repository, performing routine technical maintenance, supporting enhancements, and ensuring timely content updates per procedure.
• Assist with pharmacovigilance projects, especially those focused on operational improvements and continuous process enhancement.
• Participate in individual assessments for identification, risk evaluation, and investigation of GVP quality events or deviations affecting the GVP system.

Reporting Relationship

Reports to: Director, PSMF office

Qualifications

Education/Experience/Licenses/Certifications:

• University degree in health or life sciences, or nursing qualification (preferred).
• Minimum 5 years’ experience in the pharmaceutical industry, including at least 3–5 years in Pharmacovigilance or closely related areas (e.g., Regulatory Affairs, Clinical, Medical Information).
• Direct experience with Veeva Vault systems strongly preferred.
• Relevant professional certifications in Pharmacovigilance, Regulatory Affairs, or clinical research are considered an advantage.

Specific Knowledge, Skills, Abilities:

• Strong organizational and facilitation skills enabling efficient cross-functional project management and stakeholder engagement.
• Ability to communicate complex concepts clearly, ensuring stakeholder alignment and coordinated execution.
• Skilled in problem resolution, data flow analysis, and use of digital tools to address operational challenges.
• Proactive in risk identification and process impact assessment, escalating issues through established channels.
• Track record of managing multiple priorities and resolving issues to deliver results.
• Experience driving process improvements and digital optimization for team workflows.
• Competent in data collection, analysis, and reporting using standard PV tools.
• Proficient in processing and recording information in structured, computer-readable formats.
• Advanced capability with Microsoft Office; prior use of Veeva Vault and related PV systems is strongly preferred.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603529 : Manager, PSMF office & PV Intelligence

Experience Level

Mid Level