Job Details

  • Title: PHARMACOVIGILANCE (PV) SCIENTIST
  • Code: RCI-41518-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 09/14/2021
  • Duration: 6 Months
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  Job Description

Pharmacovigilance (PV) Scientist

Updates From Manager

  • RN and BSN will also work for this role but should have safety / pharmacovigilance exp
  • Should have a good medical background
  • Safety reporting
  • 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).
  • Review safety data and dsur contributions from safety
  • Use electronic system electronic gateway
  • Some admin tasks as well 
  • Working on some covid surveillance which is minimal
  • Safety data review
  • Support safety physician
  • Authoring safety sessions of PSUR
  • Addressing safety related queries
  • Clinical interaction as it is a phase 1 study
  • Prepping slides 
  • Minimum of 3 to 5 years BS/RN; 1 to 3 years MS/PharmD/PhD/MD, or equivalent relevant Pharmaceutical Industry experience
  • Safety pharmacovigilance exp 
  • Role would start as remote but would require to be onsite later
  • More clinical role
  • Pharmacist and PharmD people will also work for this role but should have safety / pharmacovigilance exp
Top Skills
  • PV scientist
  • Deal with clinical side of things

Functional Area Description

  • The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines.
  • The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. 

Position Summary / Objective

  • 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. 

Position 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 client 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. 

Experience Requirements:

  • 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. 

Key Competency Requirements

  • Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing 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 (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 statistic