Key Skills

Job Description

About This Vacancy Are you experienced in Pharmacovigilance and eager to contribute to the safety of medicines worldwide? In this role, you will be responsible for executing and improving PV processes, ensuring compliance, and supporting audits, inspections, and safety reporting. Executing and coordinating local Pharmacovigilance (PV) activities, ensuring compliance with legislation, regulations, and internal procedures; Processing, following up on, and reporting adverse event (Adverse Events) notifications in accordance with applicable PV guidelines; Supporting PV audits, inspections, and compliance activities, including drafting and following up on CAPAs; Preparing, maintaining, and improving PV procedures, SOPs, training materials, and other controlled documents; Managing Risk Management Plans (RMPs), safety measures, and literature screening; Monitoring the quality, archiving, and documentation of safety-related data; Advising internal stakeholders on PV regulations, processes, and compliance matters; Collaborating with health authorities, business units, external partners, and vendors; Representing Pharmacovigilance in cross-functional projects and governance structures; Supporting the PV Lead and acting as backup during absences;

Core Responsibilities

Coordinate local pharmacovigilance activities, process and report adverse events, and ensure compliance with applicable regulations and internal procedures. Support audits and inspections, maintain PV documentation and safety data, manage risk plans and literature screening, and advise stakeholders while representing PV in cross-functional work.

Requirements

The posting indicates a senior-level pharmacovigilance role and seeks someone experienced in the field. It does not specify formal education requirements, a minimum number of years of experience, or other explicit qualifications.