Vacancy expired!
PHARMACOVIGILANCE (PV) SCIENTIST SUMMIT, NJ Required Skills:
- 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.
- 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 (e.g., clinical trial laboratory data, nonclinical data, post marketing reports, scientific literature, and regulatory documents).
- Understand aspects and methods for data analysis, interpretation, and presentation.
- Possess good working skills in MS Word, Excel, and PowerPoint, including statistics.
- Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams.
- Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight.
- Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).
- Ensure pharmacovigilance regulatory compliance with oversight, as needed.
- Lead Safety Data Review (SDR) Teams and participate in related PV and product-development sub team(s).
- Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair.
- Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/sub team needs.
- Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed
- Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.
- Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
- Collaborate within and across the Client's functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
- Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities.
- Share with individuals and teams on these applied learnings.
Vacancy expired!