Associate Director Pharmacovigilance (PV) Scientist

Location
Princeton, NJ, United States
Posted
Sep 22, 2020
Ref
R1527782
Required Education
Bachelors Degree
Position Type
Full time
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.

Purpose/Objectives

Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Independently perform core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Author safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance.

Mentor less experienced scientists and teams in aspects of project management, SMT requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual or group of SMT/subteam needs.

Key Responsibilities and Major Duties
  • Lead Safety Data Review (SDR) Teams, and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting benefit/risk of key SMT activities, milestones, and documents to the SMT Chair. Mentor individuals in aspects of project management, drug development and SMT requirements, as appropriate to meet overall SMT/subteam needs.
  • Actively participate in safety and benefit/risk discussions.
  • Contribute to the execution and development of signal detection activities.
  • Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data. Provide advice and mentoring to scientists of summaries, evaluations, and conclusions.
  • Collaborate within and across BMS functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required. Provide support for audits or inspections.
  • Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, health authority (HA) commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings.
  • Author safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries. Mentor and supervise scientists' reviewing and authoring of safety data/ad hoc queries.
  • Author and contribute to sections of the PBRERs and DSURs.
  • Lead initiatives and task force groups for continuous improvement projects.


(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Key Stakeholders/Contracts: SMT Chair, Director, Team Lead Pharmacovigilance (PV) Science, Director, Safety Analytics and Reporting, Head of Epidemiology, Safety Science and Analytics (ESSA)

Qualifications:
  • BS/RN/PharmD/PhD/MD, or equivalent with relevant scientific experience and/or training discipline
  • Minimum of 8+ years BS/RN; 6+ years MS/PharmD/PhD/MD or equivalent relevant Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.


Competencies - knowledge, skills, abilities, other
  • Strong understanding of medical concepts, drug development, pharmacovigilance, risk management and global regulatory safety and risk management health authority requirements and submission milestones.
  • Strong understanding of project planning methods; demonstrated ability to manage timelines and to prioritize; ability to align operational milestones and activities with operational representatives in other functional areas. Appropriately escalates issues that could impact activity timelines or quality.
  • Ability to effectively lead and work well within cross-functional teams, using strong organizational, facilitation, and interpersonal communication skills.
  • Strong understanding and communication of scientific subject matter, including authoring scientific documents (eg, pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).
  • Attention to detail along with excellent scientific, analytical and conceptual skills. Demonstrated ability to understand, research, independently investigate, interpret, and reach reasoned conclusions regarding 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)
  • Demonstrated excellent knowledge and use of MS Office (or other equivalent BMS office suite) programs such as Excel and PowerPoint; applying technical skills to analyze and summarize scientific-medical-safety data, and to portray and summarize scientific-medical-safety concepts and teach these capabilities to others.


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.