Global Pharmacovigilance Lead

Belcan; Los Angeles (CA); Presencial; USD 90.000 - 120.000; Tempo integral

Resumo da vaga

Belcan in Los Angeles is seeking a Pharmacovigilance Specialist to provide operational support for global pharmacovigilance activities across marketed products. You will ensure deliverables meet regulatory timelines and maintain data quality.

Responsibilities include processing adverse event reports, conducting follow-up, drafting safety reports, supporting signal detection, and assisting with audits and CAPA management.

Qualificações

• Operates global pharmacovigilance activities and ensures regulatory reporting timelines.
• Processes adverse event reports and conducts necessary follow-ups.
• Reviews data in the integrated safety database and supports signal detection.
• Assists with audits, inspections and CAPA management.
• Provides training and maintains documentation per prevailing standards.

Responsabilidades

• Manage adverse event case processing including follow-up with partners.
• Notify regulatory agencies as required and respond to inquiries.
• Draft and manage periodic safety update reports.
• Participate in quality audits, CAPA actions and archiving of documents.
• Provide training and maintain training records per the plan.

Conhecimentos

Pharmacovigilance

Adverse Event processing

Regulatory reporting

CAPA management

Descrição da vaga

Belcan in Los Angeles is seeking a Pharmacovigilance Specialist to provide operational support for global pharmacovigilance activities across marketed products. You will ensure deliverables meet regulatory timelines and maintain data quality.

Responsibilities include processing adverse event reports, conducting follow-up, drafting safety reports, supporting signal detection, and assisting with audits and CAPA management.