Location: Hybrid - San Diego, CA/Minneapolis, MN OR Fully Remote
Contract: 6 months, with possibility of extension
Pay rate: $50 - $55/hour
The Drug Safety Specialist-Contractor supports a number of post-marketing and/or clinical safety activities, including, but not limited to, the handling of cases received from collaborating partners and/or identified in articles/abstracts, ensuring the uniform and timely intake, processing, and submission to regulatory agencies of individual case safety reports, if applicable. They ensure compliance with global regulations and standard operating procedures. They review clinical trial and post-marketing safety information; and assist in the preparation of periodic safety reports, and other documents, as needed.
In this role, you'll have the opportunity to:
- Ensure that clinical and/or post marketing adverse event reports are received, tracked, evaluated, 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
- Review literature articles and abstracts to identify valid ICSRs
- Perform data entry of post-marketing and clinical ICSRs into the safety database
- Complete adverse event reconciliation for ICSRs received from partners
- Manage the drug safety mailbox
To succeed in this role, you'll need:
- 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
- Experience with SDLC validation
- Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans
- Excellent written, verbal communication, and interpersonal skills
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