Senior Specialist or Manager, Pharmacovigilance, Oncology

Purpose:

This position is accountable for executing the day-to-day operations and compliance activities by leading a team of PV operations to maintain high-functioning PV systems across assigned region remit. Reports directly to Japan PV Operational Lead.

Responsibilities:

Metrics and Oversight of the Pharmacovigilance System

- Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.

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ICSR Management

- Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.

- Performs ICSR expedited reporting according to the local requirements.

- Ensures local-language medical or scientific literature review.

- Implements an appropriate local quality control (QC) procedure to ensure ...