Pharmacovigilance Specialist

$83,200 - $104,000/Yr

Logix Guru - Los Angeles, CA

Full-time - Mid Level

Remote - Los Angeles, CA

About the position

The Pharmacovigilance Specialist will provide operational support for global pharmacovigilance activities related to marketed products. This role focuses on monitoring adverse events, ensuring compliance with international regulatory guidelines, and managing safety data. The specialist will be responsible for data review, compilation, and analysis, ensuring that pharmacovigilance deliverables meet global regulatory reporting timelines.

Responsibilities

• Management of Adverse Events including processing adverse event case reports and conducting follow-up.
• Notifies regulatory agencies and business partners; responds to requests from regulatory agencies.
• Reviews scientific literature and bibliographic sources; drafts and manages periodic safety update reports.
• Evaluates safety profiles; drafts and manages signal detection reports; ensures document filing and archiving.
• Participates in the collection, processing, review, and distribution of adverse event information regarding pharmaceutical products.
• Contributes to compliance of pharmacovigilance activities including case reconciliation with concerned departments, affiliates, and distributors.
• Takes part in self-inspection visits, audits, inspections, and CAPAs management; creates or updates pharmacovigilance procedures.
• Provides training based on the training plan and manages training documentation; archives documents according to standards.
• Supports global pharmacovigilance operations such as SOPs and internal business practices.
• Serves in an advisory capacity including product monographs review and drafting responses to regulatory agencies.

Requirements

• Background in Pharmacovigilance with experience in adverse event monitoring.
• Familiarity with international regulatory guidelines.
• Experience with the ARGUS database is preferred.
• Knowledge of PSUR (Periodic Safety Update Report) processes.

Nice-to-haves

• Experience in global pharmacovigilance operations.
• Familiarity with safety data management and analysis.

Benefits

• Contract position with potential for extension.
• Opportunity to work in a global team environment.