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Bring your expertise to our global R&D Team!

Ready to advance patient safety? Join BMS in Warsaw – Poland as a Pharmacovigilance Associate II - where you’ll coordinate crucial pharmacovigilance activities, mentor colleagues, and make an impact across global drug development projects. Grow your expertise with a team dedicated to excellence in safety management!

Position Summary:The Pharmacovigilance Associate II will support Pharmacovigilance (PV) operational activities, such as tracking and following up on actions and responses of experts and other stakeholders, as well as ensuring that timelines, resources and information are coordinated and documented accurately and in a timely manner. The PV Associate II will develop subject matter expert (SME) knowledge of Safety Management Team (SMT) activities and processes and manage a Book of Work (BoW) of increased complexity. The PV Associate II will mentor the PV Associate I as they grow in role.

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 Share Point Online and One Safe SMT (Veeva Vault Safety Docs).
• 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.

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

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.

Compensation Overview:

• Warsaw
• PL: zł105.320 - zł127.617

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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.

R1598720 : Pharmacovigilance Associate II