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Pharmacovigilance (PV) Scientist

Summit, NJ

Posted: 09/12/2022 Job Number: 21742541

Job Description

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.

Project 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.
  • 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.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Maureen: maureen@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02625
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Meet Your Recruiter

Cindi Pisnoy

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