Within the Global Patient Safety department, the Periodic Reporting Manager is a key contributor in the Periodic Safety Reports (PSRs).

The Periodic Reporting Manager is responsible to coordinate the PSRs deliverables with respect of the regulatory guidelines and Ipsen standards and to ensure their readiness for distribution under the regulatory and internal timelines.

The Periodic Reporting Manager is also responsible to manage the Safety Evaluation Team meetings conducted for all Ipsen products to initiate & coordinate the PSR project team composed of internal & external PSRs contributors.

He/She is responsible to maintain and update the procedure, to participate to projects related to his/her activities.

Periodic Safety Reports (PBRER, PSUR, DSUR, SAR, RMP)

• Cooperate with PV Database/PV Analytics to design the listings requested for supporting the preparation of PSRs (working documents and regulatory documents)
• Review the coherence of the safety data presented in the listings
• Request correction to case Management in agreement with Safety Scientist to ensure the quality at case level
• Launch the preparation of PSR and coordinate its completion with the other contributors; act as a real project manager
• Control the PSR’s quality in respect of Ipsen standards and timelines
• Provide technical support in the writing of medical/PV sections of PSR
• Assist Safety Therapeutic Area team in the analysis or to respond to ad hoc Health Authority request
• Participate to the construction and maintenance of PSRs planning with Regulatory Affairs & Safety Therapeutic Area teams

Safety Meetings

• Manage the organization of Safety Evaluation Team (SET) meetings in coherence with the PSRs schedule
• Prepare the aggregate data review to support the benefit/risk assessment
• Animate the SET meetings with the internal & external key PSRs contributors
• Collaborate with Clinical, Medical Affairs teams in case of AE coding review and if necessary coordinate PV follow-up actions (PV queries, case corrections) with ICSR management team

Transversal activities

• Participate as Subject Matter Expert to the projects related to PSRs activities
• Participate to the writing and update of the documents/procedures related to the activities
• Act for process improvement in close collaboration with all Ipsen stakeholders & external providers
• Coordinate outsourced activities when applicable

• Key Required Technical Competencies:
• Training on computer/software used in Pharmacovigilance
• Knowledge on Safety evaluation, MedDRA, PV regulations
• Medical Writing skills, Use of technical expertise and support

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.