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Pharmacy Intern – Global Patient Safety
il y a 4 heures
Location:
IPSEN - Paris
**Department: GPS - Oncology Therapeutic Area
Duration: Semester Internship**
- Internship Objective
The pharmacy intern will support various activities within Ipsen's GPS Department. Specific tasks will be assigned based on ongoing projects.
This internship provides exposure to the key functions of a GPS department, including adverse event management, signal detection, safety risk assessment, and preparation of periodic safety reports. Through this experience, the intern will gain practical insights into global pharmacovigilance processes and regulatory compliance.
The intern will also collaborate with cross-functional teams such as Regulatory Affairs, Medical Affairs, and Clinical Operations.
- Main Missions / Responsibilities
- Coordination with external ICSR (Individual Case Safety Report) service provider, ensuring the quality, accuracy, and clinical relevance of case safety reports.
- Conduct a weekly review and quality check of Individual Case Safety Report (ICSR) listings to ensure accuracy and compliance.
- Participation in the preparation of periodic safety reports (DSUR/PSUR) and Risk Management Plan (RMP) for marketed and investigational products.
- Participation in signal detection, evaluation, and safety risk management activities.
- Support for pharmacovigilance activities in clinical trials, including reviews of protocols and study reports.
- Participation in cross-functional working groups and multidisciplinary project teams.
- Attendance and contribution during GPS meetings.
- This list is not exhaustive and may be adapted according to the intern's professional objectives and departmental needs.
- Required Skills and Competencies
- Knowledge of the pharmaceutical industry and drug development environment.
- Strong written and spoken English skills.
- Ability to adapt quickly and integrate into a team.
- Autonomy and strong organizational skills.
- Analytical and summarization capabilities.
- Excellent interpersonal skills and ability to work in a multidisciplinary team.
