Working Pattern: Flexible / Fractional / As Needed We are supporting a life sciences organization seeking an experienced Senior Pharmacovigilance / Drug Safety professional to provide fully remote, flexible support to an established safety team. This opportunity is ideally suited to an experienced independent contractor or consultant with a strong background in CRO environments, Argus case processing and complex early-phase oncology clinical trials. The requirement is for someone who can step in with minimal supervision, independently manage complex safety cases and provide additional capacity during fluctuating workloads.

Key Responsibilities

• Independently process complex clinical trial safety cases using Argus.
• Manage adverse event and serious adverse event (SAE) case processing, particularly in early-phase oncology trials.
• Support ICSR processing, case narratives, MedDRA coding, follow-up activities and quality control.
• Ensure accurate, timely processing in accordance with applicable regulatory requirements and procedures.
• Work collaboratively with an established safety team while requiring minimal day-to-day supervision.
• Provide flexible, fully remote support according to changing workloads and operational requirements.
• Previous or current CRO experience is mandatory.
• Strong, recent, hands-on experience with Argus.
• Demonstrable experience processing complex early-phase oncology clinical trial cases.
• Solid understanding of clinical trial pharmacovigilance, including SAE and ICSR processing.
• Ability to manage cases independently with minimal guidance.
• Excellent attention to detail and familiarity with clinical trial safety reporting requirements.
• Location: Fully Remote – USA
• Working Pattern: Fractional / Flexible / As Needed
• Hours: Variable, depending on workload and project requirements
• Duration: Ongoing support requirement, subject to business needs
• Start: To be agreed

This is not a traditional full-time contract. The opportunity is particularly well suited to an established PV contractor or consultant who has capacity to support an additional client on a flexible basis. We welcome conversations with experienced Senior Safety Associates, Drug Safety Specialists, Pharmacovigilance Consultants and other senior professionals who remain actively involved in hands-on case processing. Apply To This Job