Titre :
Alternance - Pharmacovigilance / GPS Periodic Reporting H/F, From September 2025
Société:
Ipsen Pharma (SAS)
A propos d'Ipsen:
Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.
Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.
Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.
Description de l'emploi :
Under the supervision of the Periodic Reporting Head or delegate, the Periodic Reporting Apprentice works closely within the Periodic Reporting team on the activities listed below, depending on priorities:
Planning of Periodic Safety Reports and Risk Management Plans
• Provide support in the update/maintenance of the PSR&RMP Planning in close collaboration with the Global and Local Regulatory Affairs and the GPS Therapeutic Area team
• Perform regular quality controls of the data captured in the Planning to ensure consistency of all information captured in the tool
Authoring of Periodic Safety Reports (PSUR (PBRER format), DSUR and any other Report Types) & Risk Management Plans (RMPs)
• Coordinate and/or provide support in the coordination of the authoring of the PSRs/RMP by liaising with the different stakeholders (Medical Writer(s) and internal/external Contributors and Reviewers), from the kick-off meetings and until the final internally approved PSRs are issued
• Launch the authoring of the PSRs/RMPs by convening and co-chairing (with another Periodic Reporting team member) the kick-off meetings, to which the Medical Writer(s) and all identified internal (Ipsen) and external key-Contributors and Reviewers attend, according to the Planning
• Participate to the collection and archiving of contributions provided by the multiple internal/external Contributors and to their quality control
• Review the entire PSR/RMP drafts (body and all appendices); control the quality of the content of draft and final PSR/RMP with respect of the regulatory guidelines and Ipsen standards.
Pharmacovigilance Agreements (PVAs)
• Contribute to the update of the PSR/RMP Planning with key-information from PVAs with Commercial Partners.
• Contribute to the update of the corresponding performance indicators in the PSR/RMP Authoring Tracker to be reported for PVA compliance monitoring purpose.
• Contact the Commercial Partners to ensure compliance with the PVAs throughout the PSR/RMP process: at time of planning, authoring (draft review) and final PSR/RMP distribution.
Pharmacovigilance System Master File (PSMF)
• Provide support in updating the PSMF with report-related information including feedback from the Pharmacovigilance Risk Assessment Committee (PRAC).
Periodic Reporting process and Governance
• Monitor the adherence of the Periodic Reporting activities and deliverables to regulations, internal process and Pharmacovigilance Agreements (PVAs) (when applicable), by regular review of report-related regulatory compliance, productivity and quality indicators.
• Participate to the writing and update of the quality documents (procedures and associated documents) related to the PSR & RMP activities.
Experience / Qualifications
Key Technical Competencies Required
12-month Apprenticeship minimum
#LI-Hybrid
#LI-MC1
#IpsenTraineeSquad
Dans le cadre de ses recrutements IPSEN s'engage au respect de l'égalité de traitement des candidats, indépendamment du sexe, de l'âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.
Alternance - Pharmacovigilance / GPS Periodic Reporting H/F, From September 2025
Société:
Ipsen Pharma (SAS)
A propos d'Ipsen:
Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.
Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.
Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.
Description de l'emploi :
Under the supervision of the Periodic Reporting Head or delegate, the Periodic Reporting Apprentice works closely within the Periodic Reporting team on the activities listed below, depending on priorities:
Planning of Periodic Safety Reports and Risk Management Plans
• Provide support in the update/maintenance of the PSR&RMP Planning in close collaboration with the Global and Local Regulatory Affairs and the GPS Therapeutic Area team
• Perform regular quality controls of the data captured in the Planning to ensure consistency of all information captured in the tool
Authoring of Periodic Safety Reports (PSUR (PBRER format), DSUR and any other Report Types) & Risk Management Plans (RMPs)
• Coordinate and/or provide support in the coordination of the authoring of the PSRs/RMP by liaising with the different stakeholders (Medical Writer(s) and internal/external Contributors and Reviewers), from the kick-off meetings and until the final internally approved PSRs are issued
• Launch the authoring of the PSRs/RMPs by convening and co-chairing (with another Periodic Reporting team member) the kick-off meetings, to which the Medical Writer(s) and all identified internal (Ipsen) and external key-Contributors and Reviewers attend, according to the Planning
• Participate to the collection and archiving of contributions provided by the multiple internal/external Contributors and to their quality control
• Review the entire PSR/RMP drafts (body and all appendices); control the quality of the content of draft and final PSR/RMP with respect of the regulatory guidelines and Ipsen standards.
Pharmacovigilance Agreements (PVAs)
• Contribute to the update of the PSR/RMP Planning with key-information from PVAs with Commercial Partners.
• Contribute to the update of the corresponding performance indicators in the PSR/RMP Authoring Tracker to be reported for PVA compliance monitoring purpose.
• Contact the Commercial Partners to ensure compliance with the PVAs throughout the PSR/RMP process: at time of planning, authoring (draft review) and final PSR/RMP distribution.
Pharmacovigilance System Master File (PSMF)
• Provide support in updating the PSMF with report-related information including feedback from the Pharmacovigilance Risk Assessment Committee (PRAC).
Periodic Reporting process and Governance
• Monitor the adherence of the Periodic Reporting activities and deliverables to regulations, internal process and Pharmacovigilance Agreements (PVAs) (when applicable), by regular review of report-related regulatory compliance, productivity and quality indicators.
• Participate to the writing and update of the quality documents (procedures and associated documents) related to the PSR & RMP activities.
Experience / Qualifications
- Student in Pharmacy, 6th year or Student in Health Master sector.
- Personal skills: Organized, Rigorous, Flexible, Volunteer, Curious, real wish to evolve in an International environment within a dynamic GPS Operations Team.
Key Technical Competencies Required
- Excellent planning, organizational and prioritization skills.
- Good knowledge of the EU Good Pharmacovigilance Practices (GVP).
- Good level of spoken and written English.
- Good understanding of processes.
- Good knowledge and use of Excel / Word / PowerPoint.
12-month Apprenticeship minimum
#LI-Hybrid
#LI-MC1
#IpsenTraineeSquad
Dans le cadre de ses recrutements IPSEN s'engage au respect de l'égalité de traitement des candidats, indépendamment du sexe, de l'âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.