Intake Associate, PV

AE Collection & Processing: Manage the collection, documentation, and processing of local adverse event (AE) reports from all incoming sources in compliance with national legislations and internal operating procedures.

Local Case Triage: Perform preliminary case triage including validity assessment, duplicate searches, and forwarding of cases to internal global safety teams and external business partners.

Safety System Intake: Execute accurate case intake within the Pharmacovigilance Safety System (PSS) and perform source document redactions as necessary.

Safety Surveillance & Escalation: Conduct active surveillance activities for new potential safety signals and escalate critical safety info per established guidelines.

Quality & Reconciliation: Conduct local quality checks on processed cases, perform Health Authority case downloads where required, and respond to queries from the global case processing team.

Pharmacovigilance Standards: Proficiency in local PV regulations, global safety intake standards, case validity criteria, and standard operating procedures (SOPs).

Systems: Hands-on operational data entry and workflow tracking using Pharmacovigilance Safety Systems (PSS).

Global Alignment: Collaborate effectively within the Safety Operations team to ensure zero compliance breaches on regulatory intake timelines.

Purpose-Driven Culture: Opportunity to contribute directly to Baxter's global mission to Save and Sustain Lives within an inclusive and collaborative environment.