*Please email your up to date CV to "firstname.lastname@example.org" if interested in this opportunity*
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.