Pharmacovigilance Compliance Associate

Pharmacovigilance Compliance Associate

Maternity Cover

Recordati

Puteaux, France

Job Purpose

The purpose of this function is to support QPPV Office group in its activities and maintain performance indicators on key PV processes.

Key Responsibilities

• To write and update Standard Operating Procedure (SOP) and other quality documents describing the activity of the department;
• To maintain performance indicators on key processes of PV system (KPIs: training, submissions ICSR, PBRER, DSUR, RMP, etc.);
• To maintain the key tracker to be able to provide an overview of the different PV activities;
• PV Regulatory intelligence;
• To contribute to audits/inspections preparation;
• To contribute to PV quality system control and management of findings;
• To survey and contribute to implementation of corrective and preventive actions (CAPA) related to audits/inspections/quality control;
• To contribute to the SDEA with all partners, providers and affiliates;
• Monitors the processes and workflow and implements process improvements for all projects;
• To provide necessary support (training, PV information in order to be compliance with local PV regulations and Company processes);
• To contribute to the update of the PSMF.

Required Education

• Life sciences degree;
• Specialised training in Pharmacovigilance;
• Previous experience in a Pharmacovigilance Department;
• Knowledge of EU/national pharmacovigilance requirements and experience in pharmacovigilance;
• Theoretical and practical knowledge for the performance of pharmacovigilance activities.

Required Skills and Experience

• Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment;
• Excellent organization skills and ability to handle multiple competing priorities within tight timelines;
• Ability to work across cultures;
• Initiatives and self-motivation abilities;
• Flexible and adaptable;
• Positive thinking and enthusiasm.

Required Languages

• English written and spoken.

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