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Drug Safety Specialist

  • Location: California
  • $ Salary: US$50.00 - US$55.00 per hour per hour
  • Job Type:Contract

Posted 5 months ago

  • Sector: Life Sciences
  • Contact: Yasmin Sweeney
  • Duration: 6 Months
  • Start Date: ASAP
  • Expiry Date: 16 June 2023
  • Job Ref: 92189

*Please email your up to date CV to "" if interested in this opportunity*

Job Description

A leading Biotech company are actively seeking a motivated candidate to fill their Drug Safety Specialist opportunity. This is an initial 6-month contract, with opportunity to extend/ convert to FTE. This is a remote role with a salary range of $50-55/hr depending on experience. This role involves working in the Drug Safety department and reporting to the Senior Manager, Drug Safety and Pharmacovigilance.


  • Bachelor's degree in a life science required with at least 2 years drug safety experience.
  • Excellent knowledge of FDA safety reporting requirements.
  • Experience with Argus and workflows.
  • Experience with SDLC validation.
  • Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans.

Technical Knowledge Requirements

  • Equipment: PC, scanners, facsimile (fax) machine, voice mail and e-mail systems, and common office machines, or ability to be trained.
  • Software Knowledge: Argus, Windows, MS Office (Outlook, Word, Excel).
  • Knowledge of other software required: Oracle Argus - End User-level experience.


  • Ensure that clinical and/or post marketing adverse event reports are received, tracked, evaluated including the initial assessment of seriousness, listedness/expectedness, and causality.
  • Ensure cases are processed/imported into the Argus safety database (including the authoring of narratives/queries/QC), and distributed in an efficient and timely manner and in compliance with regulations and SOPs
  • Perform E2B importing and monitoring in Argus safety database. Ensure timely and clear communication with partners for importing/transmitting issues.
  • Review literature articles and abstracts to identify ICSRs and extract the proper information for safety data processing including adverse events, procedures, and suspect products.