Senior Pharmacovigilance Associate

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.

Bring your expertise to our global R&D Team!

Position Summary:

The Senior Pharmacovigilance Associate will collaborate with cross-functional stakeholders to provide strategic and operational support across therapeutic areas for signal detection, safety data review, safety management teams, and risk management.

The position involves dedicated scientific and operational support of the portfolio through the management and implementation of effective processes monitored for continuous improvements, optimal technology solutions within safety and oversight.

The Senior Pharmacovigilance Associate will develop Subject Matter Expert (SME) knowledge of safety management team activities and manage a Book of Work (BoW) of increased complexity with minimal oversight.

The Senior Pharmacovigilance Associate will mentor PV Associate I and II and support professional development.

Duties/Responsibilities:

Signal Detection/Safety Data Review:

• Synthesizes safety data from multiple sources (e.g., clinical trials, postmarketing data, literature, cumulative analyses) to support meaningful discussion during SDRs.
• Provide subject matter expertise to contextualize emerging safety trends by considering product characteristics, indication, population, exposure, and known benefit–risk profile.
• Schedule routine Safety Data Review Meetings (SDRMs).
• Maintain Signal Tracker.

Safety Management Team (SMT):

• Facilitate and coordinate cross-functional SMTs including meeting material, SMT membership lists, mail groups, file shares, and manage related mailboxes/calendars for assigned assets.
• Set up and oversee associate systems (e.g., SharePoint, OneSafe), including access, permissions, content, and scheduling routine meetings and asset close-out.

Department Activities:

• Applies operational judgment to support timely resolution of safety‑related activities while maintaining data quality, documentation standards, and inspection readiness.
• Lead the development, maintenance, and continuous improvement of PV processes, guidance, and source materials to enhance consistency, efficiency, and quality across PV operations.

Cross Functional Activities:

• Leads process improvement and cross-functional initiatives.
• Supports clinical data gathering including tracking, reporting, querying and follow-up.
• Builds cross functional relationships with SMT membership and stakeholders.

Qualifications:

Degree Requirements:

• BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training.

Experience Requirements:

• Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.
• Minimum 3- 5 years’ professional experience in health science or relevant life sciences/medical fields, with minimum 3 years’ appropriate pharmaceutical or industry experience.
• Thorough understanding of global pharmaceutical drug development and drug lifecycles.
• Demonstrated ability in mentoring other employees.
• Demonstrated project management/leadership experience.

Key Competency Requirements:

• Strong understanding of medical concepts.
• Strong knowledge of safety activities in drug development.
• Strong understanding of project planning methods; demonstrated ability to manage timelines and to prioritize; ability to align operational milestones and activities with operational representatives in other functional areas.
• Appropriately escalates issues that could impact timelines or quality.
• Strong collaborative and communication skills with scientific subject matter.
• Excellent knowledge of Microsoft Office programs.