Category: Scientific & Clinical
- Minimum of 3 to 5 years BS/RN; 1 to 3 years MS/PharmD/PhD/MD, or equivalent relevant Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.
- Working understanding of medical concepts and some familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
- Demonstrated strong writing skills and experience in authoring and managing the production of scientific documents (eg, safety-risk related documents, clinical documents).
- Good collaborative and communication skills with scientific subject matter.
- Attention to detail along with strong 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).
- Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR)
- Lead Safety Data Review (SDR) Teams, and participate in related PV and product-development subteam(s) in a specified therapeutic area. Appropriately elevate signal detection findings impacting risk benefit to the MST Chair.
- Author PV contributions to specified sections of the PBRER and DSURs with oversight, as needed.
- Author safety data query responses to health authorities including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries with oversight, as needed.
- Periodic summary of pertinent safety-related literature, analysis of pre-determined core signal data. Provides summaries, evaluations and conclusions with oversight as needed.
- Collaborate within and across BMS functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
- Apply knowledge of product goals, strategy, partnership agreement, individual functional area responsibilities and ensure regulatory compliance.
Location: Hopewell, NJ
Duration: 6+ months