Pharmacovigilance (PV) Scientist

Madison, New Jersey

Job Title: Pharmacovigilance (PV) Scientist

Location: Madison, NJ (Onsite)

Job Type: Contract

Responsibilities:  

  • 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.
  • Collaborate within and across company 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 these applied learnings.

 
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.

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 

 

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