Quick Overview
Job Description
This is a W2 requirement, Need independent candidates (USC/ GC) only.
We are seeking a Drug Safety Specialist with 3–5 years of pharmacovigilance experience and a clinical background (RN, BSN, RPh, or PharmD) to support adverse event case processing for marketed and investigational products. The ideal candidate will manage end-to-end safety case processing, ensure compliance with FDA/ICH/Google Cloud Platform regulations, collaborate with cross-functional teams and CROs, and support clinical safety activities. Experience with Argus, ARISg, or similar safety databases, regulatory safety reporting, and oncology case processing is highly preferred.
Required Skills & Qualifications:
- Clinical degree (RN, BSN, RPh, or PharmD)
- 3–5 years of Pharmacovigilance/Drug Safety experience
- Adverse Event (AE/SAE) case processing and safety surveillance
- FDA, ICH, Google Cloud Platform, and regulatory safety reporting knowledge
- Experience with Argus, ARISg, Clintrace, or similar safety databases
- Strong clinical judgment, communication, and organizational skills
- Oncology pharmacovigilance experience is a plus
Skills
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