Drug Safety Specialist
$40/hr - $65/hr DOE
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.
Qualifications for Drug Safety Specialist:
- 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
Education Requirements 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
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