Alternance - Pharmacovigilance / GPS Periodic Reporting H/F, From September 2025

Title:

Alternance - Pharmacovigilance / GPS Periodic Reporting H/F, From September 2025

Company:

Ipsen Pharma (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:

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.

12-month Apprenticeship minimum

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#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.