Remote Senior Pharmacovigilance Specialist (CRO/Argus)

Elixir Associates LTD; United States; Teletrabalho; USD 60 000 - 120 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Fully remote

Flexible schedule

Independent contractor/consultant

Resumo da oferta

Elixir Associates LTD is seeking a Senior Pharmacovigilance/Drug Safety professional for fully remote, flexible, contract-based support to an established safety team. The role emphasizes independent case processing in CRO environments, Argus, and complex early-phase oncology trials.

The ideal contractor can step in with minimal supervision, manage SAE/ICSR cases, ensure regulatory-compliant reporting, and adapt to fluctuating workloads while remaining hands-on in safety activities.

Qualificações

• Candidates must have CRO experience and hands-on PV exposure.
• Strong experience with Argus case processing and ICSR activities.
• Experience with SAE/AE processing and MedDRA coding in oncology trials.

Responsabilidades

• Independently process complex safety cases using Argus.
• Manage AE/SAE case processing in early-phase oncology trials.
• Support ICSR processing, case narratives, coding, and QC.
• Ensure timely, regulatory-compliant safety reporting.
• Collaborate with safety team while requiring minimal supervision.
• Provide flexible, remote PV support as workloads fluctuate.

Conhecimentos

Argus case processing

CRO experience

Pharmacovigilance

SAE/AE processing

ICSR processing

MedDRA coding

Ferramentas

Argus

Descrição da oferta de emprego

Elixir Associates LTD is seeking a Senior Pharmacovigilance/Drug Safety professional for fully remote, flexible, contract-based support to an established safety team. The role emphasizes independent case processing in CRO environments, Argus, and complex early-phase oncology trials.

The ideal contractor can step in with minimal supervision, manage SAE/ICSR cases, ensure regulatory-compliant reporting, and adapt to fluctuating workloads while remaining hands-on in safety activities.