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Senior PV Scientist

Company name
Joule Inc.

Pennington, NJ

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Job Description
 Senior PV Scientist Must haves: -BS/RN with 6-9 years pharma experience or MS/PharmD/PhD/MD with 4-6 years pharma experience -Good working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.  -Demonstrated strong writing skills and experience in authoring and managing the production of strategic scientific documents (eg,safety-risk related documents, clinical documents, PBRER, DSURs). -Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents). Responsibilities  1. Lead Safety Data Review (SDR) Teams, and participate in related PV and product-development subteam(s) in a specified therapeutic area. Appropriately elevate issues impacting key MST activities, milestones, documents to the MST Chair with limited or no oversight as needed.  2. Mentor individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs. 3. Author PV contributions to specified sections of the PBRER and DSURs with limited or no oversight as needed. 4. Periodic review and summary of pertinent safety-related literature, analysis of pre-determined core signal data with limited or no oversight as needed. Provides advice and mentoring to scientists of summaries, evaluations and conclusions. 5. Author safety data query responses to health authorities including coordination and integration of input from otherfunctional groups, as needed to support responses to ad hoc queries with limited or no oversight as needed. Mentor and supervise scientist review and authoring of safety data queries as appropriate. 6. Collaborate within and across BMS functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required with limited or no oversight as needed.  7. Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings.  Location: Hopewell, NJ Duration: 6 months

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Joule Inc.
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