Job Description

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide 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 Pharmacovigilance Associate is a member of a Patient Safety group which coordinates, tracks and analyzes medical safety assessments, surveillance and data in clinical development activities.

Position Responsibilities

SMT 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. 

• Plans and organizes requirements and/or resources based on Book of Work (BoW) and other upcoming tasks and activities for assigned product portfolio with oversight.

• Applies medical, life science and general scientific knowledge and expertise to create and manage plans for designated projects with oversight.

Signal Detection Support

• Schedules Safety Data Review meetings and attends as able.

• Generate and file AWARE reports and collaborate with Safety Analytics & Reporting (SAR), as needed.

• Responsible for safety signal log entry.

• 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.

• Execute Pharmacovigilance Agreement (PVA) searches.

• Provide administrative support, system and documentation support.

• Manage access, permissions and content related to SMT SharePoint Online.

• 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 backup coverage to PV Associate II role, as needed.

Requirements

• Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.

• Minimum of 2 years' professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience.

• Demonstrated understanding of global pharmaceutical drug development and drug lifecycles.

Qualifications:

• 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

Other Qualifications

• US military experience will be considered towards industry and professional experience requirements

Key Competency Requirements

• Working understanding of medical concepts and some familiarity with safety activities in drug development

• Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.

• Ability to work well in cross-functional teams. Good collaborative and communication skills with scientific subject matter.

• Attention to detail with scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, post-marketing reports, scientific literature and regulatory documents).

• Understand aspects and methods for data analysis, interpretation and presentation.

• Possess good working skills in MS Word, Excel, PowerPoint, SharePoint Online and Outlook.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.