Pharmacovigilance, Associate I

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.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

The Pharmacovigilance Associate is a member of the Epidemiology, Safety Science, Capabilities, and Innovation group which coordinates, tracks and analyzes medical safety assessments, surveillance and data in clinical development activities.

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.
  • 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.


Administrative 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.

Ideal Candidates 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

Other Qualifications

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

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.

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 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.

R1547225-en-us