Pharmacy Intern - Global Patient Safety, GPS Compliance Team

Title:

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

Company:

Ipsen Innovation (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

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 (PV) regulations and internal standards.

This internship provides experience of a global PV system and its 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 PV requirements.

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

2. Main Missions / Responsibilities

- Safety Regulatory Intelligence: Contribution to the safety regulatory intelligence activity, monitor PV regulations updates and follow-up the impact assessment of new regulatory information, and implementation of appropriate actions.

- 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.

- EEA 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 activities.

- 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.

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