Drug Safety Specialist
Atrium Staffing - Princeton, NJ

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Drug Safety Specialist


Practice Area:
$40/hr - $65/hr DOE

New Jersey
Bachelor's Degree

Full Time
Our client is a pharmaceutical company located in Princeton, NJ who is looking to hire a Drug Safety Specialist. The Drug Safety Specialist role is a temporary opportunity lasting approximately 6 months.

Responsibilities of Drug Safety Specialist:

Process serious adverse event reports, including triage, book-in, case preparation, submission and querying for follow-up information. Participate in query process, reconciliation process, submission process. Execute the Drug Surveillance program including the intake, evaluation, processing, and follow-up on adverse reports, in compliance with government regulations.
  • Triage reports to ensure timely processing consistent with global regulatory requirements
  • Execute book-in procedure into safety database
  • Process adverse event data in a manner which produces prompt, accurate individual case safety reports, communicating with each global safety department, as necessary
  • Conduct follow-up querying with reporter to clarify data for accuracy as well as capture additional relevant data
  • Maintain knowledge of regulatory requirements
  • Communicate with medical directors to ensure accurate individual case safety reports
Qualifications for Drug Safety Specialist:
  • 3-5 years of experience in drug safety
  • Knowledge of FDA compliance requirements
  • Knowledge of computerized safety data entry and MedDRA
  • Demonstrated ability to learn new software applications
  • Knowledge of Microsoft Office
Education Requirements for Drug Safety Specialist:
  • PharmD or RN

About this company
28 reviews
Founded in 1995, Atrium Staffing is a privately held, woman-owned staffing and recruitment firm with revenues grossing over $100M. Atrium...