Pharmacovigilance Associate II

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

Benefits offered by this job

Hybrid work model

Incentive cash and stock opportunities

Job summary

Bristol Myers Squibb in Warsaw, Poland, is seeking a Pharmacovigilance Associate II to support PV operations, mentor colleagues, and contribute to safety management across global drug development projects. You will coordinate SMT activities and manage a Book of Work, ensuring timely actions and clear communication.

We are looking for a professional with PV experience, strong data analysis, and mentoring abilities.

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: PV processes expertise, data analysis, project management, and cross-functional teamwork.

Responsibilities

• Support SMTs and coordinate cross-functional SMTs and assigned sub-teams; document decisions, timelines and action items in team minutes.
• Develop plans for designated projects with minimal oversight based on BoW and upcoming tasks.
• Schedule Safety Data Review meetings; generate and file signal detection reports and collaborate with SAR.
• Provide SME support and training for PV Associate processes and contribute to process guides.
• Assist CSP-related activities and participate in regulatory inspections preparation and internal document updates.

Skills

Pharmacovigilance

Data analysis

Mentoring

Cross-functional teamwork

Scientific communication

Project management

Education

Bachelor of Science in life sciences

Job description

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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Bring your expertise to our global R&D Team! Ready to advance patient safety? BMS in Warsaw - Poland is seeking to recruit 4 Pharmacovigilance Associates II. Join our global R&D organization 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 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.

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. #LI-Hybrid

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 [e-mail]. 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 [e-mail]. 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 Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.