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Company Description

This position is accountable for executing the day‑day operations and compliance activities to maintain high‑functioning PV systems across assigned region remit. Reports directly to PV Operational Team Lead OR Regional PV 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.

Quality Management System

- Develops and maintains local/regional procedures in line with corporate procedures and local requirements.
- Performs the impact assessment of new/updated corporate policies, process, and procedures.
- Actively assists with the PV Exception Reporting/CAPA process.
- Actively assists with the business continuity plan and testing.
- Develops and maintains the local PSMF in line with AbbVie’s PV system master file, when required by local/regional regulations.

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 quality of information entered and reporting decisions.
- Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with general procedures.

Periodic Safety Reporting

- Leads the preparation of periodic safety reports (e.g., PSUR), local annexes, local variations, and translation of safety deliverable documents.
- Ensures submission of periodic safety reports and ensures documentation of evidence.

Audits and Inspection Management

- Actively assists in managing internal PV audits, audits of affiliate service providers/third.

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Postúlate en Kit Empleo: kitempleo.cl/empleo/1djwvw

📌 Pv Operational Associate (Santiago)
🏢 Abbvie
📍 Santiago