Solicited Programs Associate

il y a 3 semaines

Les Ulis, France IPSEN Temps plein

**Title**:
Solicited Programs Associate - 6 months

**Company**:
Ipsen Innovation (SAS)

Within the Global Patient Safety (GPS) organization, the Solicited Programs Associate will ensure full compliance with efficient processes for safety-related aspects of all solicited programs conducted at Ipsen which comprise: interventional clinical trials, non-interventional studies (NIS),Investigators Sponsored Studies (ISS) and patient data collection systems (PDCS) which encompass different types of Ipsen programs such as Patient Support Programs, Early Access programs, Market Research Programs etc.

This requires a good working knowledge of clinical development, pre
- and post-marketing pharmacovigilance processes and legislation.

The position will report directly to the Global Patient Safety Solicited Programs Director.

6-month fixed-term contract.

**Main responsibilities and tasks**

**Safety-related aspects of interventional clinical trials**
- Work collaboratively with the Global Solicited Programs Team members to ensure that all current PV requirements for interventional clinical trials are effectively incorporated into Ipsen processes and documented in SOPs
- Contribute to the review of Protocols, SAE Reconciliation Plans to ensure that PV requirements are covered and design user guide specific to the safety collection/reporting rules
- Manage the monitoring of relevant Key Performance Indicators (KPIs), and implement corrective and preventive actions (CAPAs) as required
- Assist Ensure that all changes in legislation relating to PV requirements for interventional clinical trials, in the region, are proactively incorporated into Ipsen processes so that there is no loss of compliance and business continuity is maintained

**Safety-related aspect of Patient Data Collection Systems (PDCS)**
- Contribute to the maintenance and continuous improvement of PDCS & Digital Media Pharmacovigilance processes and their corresponding quality documents (Standard Operating procedures (SOP), Forms, Instructions)
- Ensure that PDCS process is well implemented across the Ipsen organization
- Work in close collaboration with Global & Local Medical Affairs team to ensure that PDCS are set up & managed within Ipsen in compliance with internal procedures & global/ local regulations
- Coordinate the Maintenance of the logs of all PDCS and Digital Media according to the SOPs
- Contribute to the review of Protocols, SAE Reconciliation Plans to ensure that PV requirements are covered and design user guide specific to the safety collection/reporting rules
- Contribute to the review of appropriate PV agreements/ PV Clauses when the programs involved a third party and/or licence Partner
- Maintain that all PDCS and Digital Media are ‘certified’ to meet PV requirements before they start
- Track compliance with PV requirements for PDCS and Digital Media, and implement corrective and preventive actions (CAPAs) as required
- Ensure documentation that Source Data verification is performed as per Ipsen SOP and/or PV agreement and take appropriate actions as required

**Safety-related aspect of Non-interventional studies (NIS)**
- Ensure that the Non-interventional studies (NIS) SOP is well followed & implemented across Ipsen organization
- Contribute to the review of Protocols, SAE Reconciliation Plans to ensure that PV requirements are covered and design user guide specific to the safety collection/reporting rules
- Maintain and manage a log of all NIS, to enable tracking of the progress of the studies, and study completion in order to assure the receipt of the study report and inclusion of this into signal detection activities for the respective product
- Implement corrective and preventive actions (CAPAs) as required for any deviations from the NIS PV requirements

**Compliance - Training, audits & inspections, and best practices**
- Ensure that appropriate training of relevant internal and vendor staff for these processes, as applicable
- For all audits and inspections, serve as the GPS support for these processes, which includes:

- Pre-work in preparation for the audit/inspection
- Direct interviews with auditors/inspectors, as required
- Follow-up on any subsequent actions and CAPAs
- Keep alert to opportunities to promote examples of best practice across the multiple users of these processes, and ensure that these opportunities are taken
- Develop new documentation, participate in the development of Solicited Programs team and design user guides/training
- Perform other related duties within the scope of the Solicited Programs as assigned

**Experience / Qualifications**
- Biosciences graduate, or experienced healthcare professional
- Fluent in written and spoken English
- Global mindset and intercultural awareness, capability to understand specificities of each site, presence on the different sites
- At Least 2 to 3 years of Pharmacovigilance experience with a strong focus on Solicited programs
- Good working knowledge of clini

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