Pharmacovigilance Associate II

Pharmacovigilance Associate II

BMS - Bristol-Myers Squibb

Warsaw, Poland

Duties/Responsibilities:

Safety Management Team Support:

• Supports Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional SMTs and assigned sub-teams, such as Safety Data Review (SDR) Teams.
• Creates meeting agendas for SMT and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.
• Identifies post-meeting actions, and ensures responsibilities and timelines are assigned and met.
• Assesses and appropriately elevates issues impacting key SMT activities, milestones, documents to the appropriate WWPS colleagues.
• Leads, plans, and organizes requirements and/or resources based on BoW and other upcoming tasks and activities for assigned product portfolio with minimal oversight.
• Applies medical, life science and general scientific knowledge and expertise to create and manage plans for designated projects with minimal oversight.

Signal Detection Support:

• Schedules Safety Data Review meetings and attends as able.
• Generate and file signal detection reports and collaborate with Safety Analytics & Reporting (SAR), as needed.
• Signal log entry and signal log report outputs.
• Execute literature searches, deliver output, and retrieve full-text articles, as applicable, applying critical thinking and independent research skills to ensure the information is appropriate and usable. Liaise with literature vendor(s).
• Execute Pharmacovigilance Agreement (PVA) searches.

Administrative Support:

• Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.
• Manage access, permissions and content related to SMT SharePoint Online and OneSafe SMT (Veeva Vault SafetyDocs).
• Manage study information received in PV mailbox.
• Maintain SMT membership lists, mail groups, and file shares.
• Manage MSAPSMT mailbox/meeting calendar for assigned product portfolio.

Other Activities:

• Work collaboratively with Clinical Safety Program Leads to successfully execute CSP-related activities for protocols, including tracking, reporting, querying, follow up in EDC system, etc. (TAO/RAVE).
• Participate in process improvement projects and implementation.
• Support preparation for regulatory inspections.
• Close safety-related health authority queries in Verity.
• Provide subject matter expert (SME) support for PV Associate processes and provide training.
• Contribute to process guides and maintain source materials. Lead internal document updates and provide feedback during review periods.
• Provide backup coverage to Sr. PV Associate role, as needed.

Qualifications:

• Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.
• Minimum 3 years’ professional experience in health science or relevant life sciences/medical fields, with minimum 2 years’ appropriate pharmaceutical industry or academic experience.
• Strong understanding of global pharmaceutical drug development and drug lifecycles.
• Demonstrated ability in mentoring other employees.

Ideal candidate 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 in working with committees and diverse teams.