Pharmacy Intern – Global Patient Safety (GPS) / GPS Compliance TeamIPSEN

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Pharmacy Intern - Global Patient Safety (GPS) / GPS Compliance Team

Location: IPSEN - Paris

Department: GPS Department / QPPV Office / Compliance Team

Duration: Semester Internship

1. Internship Objective

Within the Compliance Team (part of the QPPV Office) in the Global Patient Safety (GPS) department, the pharmacy intern will support a broad range of compliance activities to ensure adherence to pharmacovigilance regulations and internal standards.

This internship provides experience of a global pharmacovigilance system and its regulatory compliance aspects, including but not limited to PV system monitoring, compliance oversight, quality events, change control, and participation in audits and inspections impacting the department.

Through this experience, the intern will gain practical insights into different aspects of the PV system and will have the opportunity to be part of the QPPV Office, a key function ensuring compliance with pharmacovigilance requirements.

The intern will also collaborate with cross-functional teams such as Global Quality, Global Regulatory Affairs.

2. Main Missions / Responsibilities

- Safety Regulatory Intelligence: Contribution to the maintenance and update of the safety regulatory intelligence system to monitor PV regulations updates.

- Compliance monitoring, Performance Indicators (PIs/KPIs) : Maintenance and continuous improvement of the PV quality system by the monitoring of the Performance Indicators (PIs/KPIs) and compliance data.

- Quality Events / Deviations Management: Coordination of investigations and root cause analyses to ensure proper identification of compliance gaps and implementation of CAPA.

- Pharmacovigilance System Master File (PSMF): Support team for the maintenance and update of the EEA PSMF.

- Inspections and Audits: Support the preparation, conduct, and follow-up of inspections and audits impacting GPS department.

- Training : participation to GPS training projects.

- Other Compliance Activities or Projects: Participate in any other GPS compliance activities or projects as needed.

Specific tasks will be assigned based on ongoing projects.

This list is not exhaustive and may be adapted according to the intern's professional objectives and departmental needs.

3. Competencies and Knowledge

• Knowledge of the Pharmaceutical Industry and Drug Safety.
• Fluent in English.
• Ability to adapt quickly and integrate into a team.
• Autonomy and strong organizational skills.
• Analytical and summarization capabilities.
• Interpersonal skills and ability to work in a multidisciplinary team.