Pharmacovigilance (PV) Scientist

Our client, a leading Pharmaceutical company is hiring a Pharmacovigilance (PV) Scientist on a  contracting basis.

Work Location: Summit NJ

Summary:

• 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 subteam(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/subteam 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.
• Prep for monthly safety review meetings.
• Update investigative brochures.
• Answer safety questions from colleagues.

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 postmarketing and global safety health authority requirements.
• 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).
• Understand aspects and methods for data analysis, interpretation and presentation.
  Possess good working skills in MS Word, Excel and PowerPoint, including statistics.
• Oncology Phase I studies experience required.
• Safety data analysis experience required.
• DSUR experience – providing input.