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Pharmacovigilance (PV) Specialist - remote

  • Location: United States of America
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 15 days ago

Pharmacovigilance (PV) Specialist for Clinical Trial Coordination role - growing CRO - Full Time role - fully remote

Growing and exciting niche focused CRO are urgently seeking a Pharmacovigilance Specialist with a strong PV (SAE reports etc ) and/or IRB/regulatory background to perform a hybrid role and taking on duties of a Clinical Trial Specialist/Coordinator for a really interesting function in the business. This is an FTE role, fully remote and offers a competitive salary, health/dental/vision insurance, 401k with match, PTO, company holidays and more.

We are seeking the following individual for this role:

A candidate with 2+ years' experience of working with Pharmacovigilance (PV) data, ideally in a drug safety team

Relevant experience includes receiving SAE from multiple sites/studies, processing SAEs in SAE system, drafting SAE reports for Medical Monitor Review, submitting SAE reports to Sponsor for IRB reporting, managing SAE system, understanding of SAE reporting process and IRB SAE reporting timelines etc

Strong IRB regulatory knowledge/understanding

An interest in learning how to be a Clinical Trial Specialist/Coordinator (some prior experience would be helpful but is not mandatory)

If you meet the above criteria and are available, please apply immediately with your latest resume for consideration. We are looking to fill this role within 2-3 weeks.