Job Description

Objectives

Coordinate Pharmacovigilance activities across Europe contributing to the robustness of the Ipsen PV System performed in Europe by Ipsen affiliates and Commercial partners acting as a local PV representative by supporting the Ipsen Affiliate Pharmacovigilance Offices, to deliver the Ipsen Pharmacovigilance System, and associated quality system, such that all affiliate PV processes are efficient and cost-effective, consistent with Ipsen standards, and delivering full compliance with all regulatory authority requirements worldwide. Review and approve PV documentation supporting the execution of PV requirements in the

Patient Data Collection System (PDCS)

and Digital Media (DM)

sponsored by Ipsen in Europe

Main responsibilities

Actively support the GPS Regional Team in contributing to a strong

oversight of

all Pharmacovigilance activities

performed in Europe by Ipsen Affiliates and Ipsen partners Actively support the Ipsen Affiliate Pharmacovigilance Offices to

maintain their Ipsen Pharmacovigilance System

in accordance with Ipsen global policies and regulations in place. Actively support the GPS Regional Team in

ensuring compliance

at Affiliate and partner level with the defined processes/contracts Actively support the GPS Regional team in reviewing and approving PV documentation supporting the

Patient Data Collection System (PDCS)

and Digital Media (DM)

sponsored by Ipsen in Europe.

Detailed missions:

Participate to the catch-up meetings hosted by the GPS Regional team with each Affiliate PV team in Europe Contribute to the redaction of meeting minutes and pending actions discussed Coordinate pending actions from catch up meetings with other stakeholders within the GPS organization, other global departments, and the affiliate. Contribute to catch-up meeting preparation, especially: Catch-Up Meeting Minutes preparation


Affiliate PDCS Compliance / ATOLS review


Affiliate DM Compliance / Comando review


Affiliate Monthly Report Check
Coordinate any request asked by GPS to the Affiliates in Europe for GPS Regional team oversight Assist in the slide preparation for Monthly Affiliates meetings and GPS organization. Coordinate the implementation of relevant changes of global quality documents impacting the affiliate processes Support each affiliate who raise any question related to Ipsen requirements by coordinating the answer with the Subject Matter Expert and providing feedback to the respective affiliate Conduct Quality checks of the monthly reports completed by each affiliate and partners PV teams in Europe to ensure data provided is accurate, comprehensive, and exhaustive. Escalate any issue identified to the GPS Regional Lead and Manager Assist the GPS Regional Team in the PV certification of PDCS and DM Participate, together with the GPS Regional Lead or GPS Regional Manager, in the Affiliate PV Audit preparation and assist in reviewing Affiliate PV Audit responses

Qualification

Education / Certifications

Fluent in written and spoken English Have a basic knowledge of pharmaceutical industry and Good Pharmacovigilance Practices Pharmacy degree

Technical competencies

Ability to work in a matrix environment Team player with good networking Ability to prioritise own workload, work under pressure and achieve strict timeline targets * Good verbal and written communication skills