Senior Manager, Pharmacovigilance Associate

Senior Manager, Pharmacovigilance Associate

BMS - Bristol-Myers Squibb

Warsaw, Poland

Join our Pharmacovigilance team in Warsaw as a Senior Manager, PV Associate. In this key leadership role, you’ll guide a team supporting global safety activities and cross‑functional collaboration. A great opportunity for an experienced PV professional ready to make an impact.

Functional Area Description:

The Patient Safety organization 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.

Position Summary:

The Senior Manager, Pharmacovigilance Associate oversees the Pharmacovigilance (PV) associate team which 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 Senior Manager, Pharmacovigilance Associate is responsible for managing and allocating the work of the team of PV Associate team as serving as a subject matter expert (SME) for Safety Management Team (SMT) processes, manages a complex and evolving Book of Work (BoW), and partners with WWPS stakeholders to ensure consistent, compliant, and efficient execution.

The Senior Manager, Pharmacovigilance Associate mentors, and develops PV Associate team members, providing coaching, oversight, and performance guidance to build capability, accountability, and operational excellence.

Duties/Responsibilities:

Signal Detection/Safety Data Review:

• Lead, manage and mentor the team on the synthesis of safety data from multiple sources (e.g., clinical trials, postmarking data, literature, cumulative analyses) to support meaningful discussion during SDRs;
• Contextualize emerging safety trends by considering product characteristics, indication, population, exposure, and known benefit–risk profile;
• Schedule routine Safety Data Review Meetings (SDRMs);
• Ensures the maintenance of Signal Tracking, including support of the process.

Safety Management Team (SMT):

• Ensures the facilitation and coordination of cross-functional SMTs including meeting material, SMT membership lists, mail groups, file shares, and manage related mailboxes/calendars for assigned assets;
• Executes and/or directs the set up and oversight of associate systems (e.g., SharePoint, OneSafe), including access, permissions, content, and scheduling routine meetings and asset close-out.

Department Activities:

• Expertly applies operational judgment to support timely resolution of safety‑related activities while maintaining data quality, documentation standards, and inspection readiness;
• Executes and/or directs 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:

• Drives/leads process improvement and cross-functional initiatives;
• Oversees clinical data gathering including tracking, reporting, querying and follow-up;
• Builds cross functional relationships with SMT membership and stakeholders.

Leadership and Team Development:

• Facilitate skill development by coaching others and sharing expertise;
• Provide team members with regular and constructive performance feedback;
• Build a collaborative, supportive learning environment and ensure high-quality delivery of pharmacovigilance activities.

Qualifications:

Degree Requirements:

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

Must Have Requirements:

• Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training;
• Minimum 5 years relevant Pharmacovigilance/Pharmaceutical Industry experience. Line management experience is preferred;
• Demonstrated ability in mentoring others;
• Thorough understanding of global pharmaceutical drug development and drug lifecycles;
• Demonstrated project management/leadership experience.

Ideal Candidates Would Also Have:

• Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes;
• Extensive experience in the analysis and communication of data and information to key stakeholders;
• Project or program management experience and/or qualifications;
• Experience leading committees and diverse teams.

Key Competency Requirements:

• Strong understanding of medical concepts;
• Strong knowledge of safety activities in drug development;
• Demonstrated ability to manage timelines, quality of work and prioritization for complex and or numerous projects/programs;
• Ability to align operational milestones and activities with operational representatives in other functional areas;
• Adaptable/flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism);
• Appropriately escalates issues that could impact timelines or quality;
• Excellent collaborative and communication skills with scientific subject matter;
• Excellent knowledge of Microsoft Office programs.