Pharmacovigilance Associate (Contract) | Remote
Pharmacovigilance Associate (Contract) | Remote
- 6-month contract, extension or conversion to FTE available
- 40 hours/week
We're partnering with an innovative biotech organization seeking a Pharmacovigilance Associate to support day-to-day drug safety operations. This role is ideal for someone with early-career pharmacovigilance experience who is looking to expand their expertise in case processing, safety systems, and regulatory compliance reputed company a fast-paced environment. Key Qualifications:
- 1-3 years of pharmacovigilance or drug safety experience
- PharmD preferred
- Hands-on ICSR case processing and QC experience
- Experience in safety databases, including end-to-end case workflow (intake through submission/distribution), case follow-up, and data quality activities.
- Working knowledge of global PV regulations and guidelines (e.g., ICH E2A/E2B(R3)/E2D; FDA/EMA reporting concepts) and pharmacovigilance SOPs.
- Experience with medical coding conventions and safety data quality practices.
What You'll Do:
- Support adverse event case processing and quality review activities
- Assist with safety data management and reconciliation efforts
- Collaborate with cross-functional stakeholders and external partners
- Contribute to inspection readiness and process improvement initiatives
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