Remote Pharmacovigilance Operations Manager - Part-Time Contract

Mykelly; New York (NY); Remote; USD 103.000 - 124.000; Teilzeit

Zusammenfassung

Mykelly is seeking a Pharmacovigilance Operations Manager for a remote, part-time six-month contract in the United States. The role focuses on a safety database transfer, Argus Safety, ICSR processing, and ICH E2B(R3), with about 20 hours per week.

You will work independently in a remote environment, collaborating with internal teams, CROs, vendors, and project partners to ensure accurate, compliant pharmacovigilance operations in a timely manner.

Qualifikationen

• Five+ years in pharmacovigilance
• Hands-on safety database setup, transfer, or migration
• Strong experience with Argus Safety
• Experience processing Individual Case Safety Reports (ICSRs)
• Familiarity with ICH E2B(R3) reporting standards

Aufgaben

• Plan and execute pharmacovigilance safety database transfers or migrations
• Assist with database setup, mapping, transfer, reconciliation, validation, and quality checks
• Provide backup for ICSR intake and case processing
• Maintain accurate safety case information in Argus Safety
• Support electronic safety reporting and ICH E2B(R3) requirements
• Identify and help resolve data discrepancies and transfer issues
• Collaborate with internal teams, CROs, vendors, and project partners

Kenntnisse

Pharmacovigilance

Argus Safety

ICSR processing

ICH E2B(R3)

Data mapping

Jobbeschreibung

Mykelly is seeking a Pharmacovigilance Operations Manager for a remote, part-time six-month contract in the United States. The role focuses on a safety database transfer, Argus Safety, ICSR processing, and ICH E2B(R3), with about 20 hours per week.

You will work independently in a remote environment, collaborating with internal teams, CROs, vendors, and project partners to ensure accurate, compliant pharmacovigilance operations in a timely manner.