Category: Scientific & Clinical
Title: Pharmacovigilance Scientist
Location: Hopewell, NJ
- Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams.
- Appropriately perform core signal detection activities, elevate program or portfolio issues impacting benefit risk, priorities, resources, milestones with appropriate oversight.
- Author safety data query responses, contribute to specified sections of the Periodic Benefit Risk Update Report (PBRER) and Development Safety Update Report in a specified therapeutic area.
- Ensure pharmacovigilance regulatory compliance with oversight, as needed.
- 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 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.
- BS/RN/MS/PharmD/PhD/MD, or equivalent with relevant scientific experience and/or training discipline
- 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 postmarketing 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).
- 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 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, postmarketing reports, scientific literature, and regulatory documents).
- Software that must be used independently and without assistance (e.g., Microsoft Suite)
- Understand aspects and methods for data analysis, interpretation and presentation. Possess good working skills in MS Word, Excel and PowerPoint.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.