Pharmacovigilance Associate II – Hybrid (Remote 50%)

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 105,000 - 128,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland is seeking to recruit 4 Pharmacovigilance Associate II to support PV operational activities and coordinate SMT actions across portfolios. You will mentor PV Associates and manage a Book of Work with increasing complexity.

In this hybrid role, you will schedule Safety Data Review meetings, file signal detection reports, and liaise with Clinical Safety and SAR teams while maintaining timely documentation and quality standards.

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.

Responsibilities

• Supports Medical Safety Assessment Physicians in leading and coordinating SMTs and assigned sub-teams.
• Creates meeting agendas for SMT and assigned sub-teams, and documents 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.
• 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.
• 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.
• 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.

Skills

Mentoring

Cross-functional coordination

Documentation

Education

Bachelor of Science in life sciences

Job description

Bristol Myers Squibb in Warsaw, Poland is seeking to recruit 4 Pharmacovigilance Associate II to support PV operational activities and coordinate SMT actions across portfolios. You will mentor PV Associates and manage a Book of Work with increasing complexity.

In this hybrid role, you will schedule Safety Data Review meetings, file signal detection reports, and liaise with Clinical Safety and SAR teams while maintaining timely documentation and quality standards.