Yann David Email & Phone Number

Paris, Fr

Boulogne Billancourt, Fr

Oversight of local third parties with an impact on the global and local Ipsen PV systems- Support the Ipsen Affiliates in the establishment and maintenance of local pharmacovigilance agreements with local commercial partners and service providers.- Support Ipsen Affiliates in the establishment of local service agreements with local PV service providers and ensure the oversight of the local service providers by Ipsen Affiliate is conducted as per Ipsen standard processes.- Maintain, with the support of Ipsen Affiliates, of the list of local third parties with an impact on the global and local Ipsen PV system.Oversight of global commercial partners acting as local PV representative on behalf of Ipsen:- Support the Global Patient Safety Regional Lead in ensuring the compliance of Partners to the applicable SDEA and applicable local PV regulation.- Collect metrics and information on PV activities performed by Ipsen’s Commercial Partners acting as local PV representative.- Ensure the appropriate level of oversight of such Partners by Ipsen Global Patient Safety.Ensure up-to-date service level agreements between Global Patient Safety and Ipsen Affiliates are in place and comply with Ipsen processes and applicable regulations.Project manager for the selection, qualification and management of a global service provider for local PV activities:- In collaboration with the Strategic Sourcing and Procurement, establish the selection strategy and drive the process of selection of a global service provider for local PV activities.- Define the transition plan and coordinate the switch of Ipsen Affiliate from the current local PV service provider to the global service provider for local PV activities.- Ensure, at global and local level, the appropriate level of oversight of the global service provider for local PV activities in collaboration with applicable global functions and Ipsen Affiliates.

Boulogne Billancourt, Fr

Oversight of local third parties with an impact on the global and local Ipsen PV systems- Support the Ipsen Affiliates in the establishment and maintenance of local pharmacovigilance agreements with local commercial partners and service providers.- Support Ipsen Affiliates in the establishment of local service agreements with local PV service providers and ensure the oversight of the local service providers by Ipsen Affiliate is conducted as per Ipsen standard processes.- Maintain, with the support of Ipsen Affiliates, of the list of local third parties with an impact on the global and local Ipsen PV system: - Ensure the appropriate classification of local third parties for inclusion in the Ipsen PSMF and accuracy of this list of local third parties for contribution to the Ipsen PSMF. - Implementation of Microsoft SharePoint tool to facilitate the exchange of information about local third parties between Ipsen Affiliates and Ipsen Global Patient Safety and ensure the timely update of the list of local third parties.Oversight of global commercial partners acting as local PV representative on behalf of Ipsen:- Support the Global Patient Safety Regional Lead in ensuring the compliance of Partners to the applicable SDEA and applicable local PV regulation.- Collect metrics and information on PV activities performed by Ipsen’s Commercial Partners acting as local PV representative.- Ensure the appropriate level of oversight of such Partners by Ipsen Global Patient Safety.Ensure up-to-date service level agreements between Global Patient Safety and Ipsen Affiliates are in place and comply with Ipsen processes and applicable regulations.

Management of the Vigilance Compliance Unit (4 team members) and its activities: - Maintenance of the pharmacovigilance quality system: management of pharmacovigilance-related deviations and CAPAs, management of the pharmacovigilance quality document system and related trainings, audit and inspection readiness activities- Maintenance of the Global PSMF- PV Awareness training- Management of pharmacovigilance partners and related agreements- Management of subsidiaries and support in the maintenance of local pharmacovigilance systems- International regulatory intelligence- Conduct of pharmacovigilance partners audits

- Maintenance of the Global Pharmacovigilance System- Oversight of local vigilance systems and global point of contact for local vigilance-related topics: implementation, development and maintenance of local vigilance systems and hormonization of such systems within Biocodex' Subsidiaries- Global and Local Audits and Inspections preparation and management, findings and CAPAs management and follow-up- Regulatory intelligence- Management of Safety Data Exchange Procedures/Agreements- PV Auditor

Paris, France, Fr

Implementation of a pharmacovigilance Business Partner and Service Provider audit program:- Support in the management of the annual Business Partner Pharmacovigilance Quality Risk Assessment: establishment of a survey for the assessment of Global and Local Business Partners with established Safety Data Exchange Agreements, monitoring of project progress at global and local level, QC/QA and analysis of the results for the selection of Business Partners to be included in the audit plan.- Management of Business Partner and Service Provider pharmacovigilance audits: establishment of the annual audit plan, preparation of audits in close collaboration with auditors and relevant functions internally and at Business Partner's level, support during audits and follow up of audit outcomes.- Development of a questionnaire for the assessment of Business Partner's pharmacovigilance system.Management of FDA inspection: - Preparation of pharmacovigilance inspection at Global/Local level.- GCP pre-authorization inspections (preparation of the inspection and support to the clinical team for the pharmacovigilance related topics during inspections).Management of internal pharmacovigilance process audits and Business Partner audits hosted by Sanofi: - Audit preparation- Support during audits (backroom lead).Development of a standard pharmacovigilance database extract template to be used for audit and inspection (GVP, GCP, GMP).

Paris, France, Fr

Implementation of a pharmacovigilance Business Partner and Service Provider audit program:- Support in the management of the annual Business Partner Pharmacovigilance Quality Risk Assessment: establishment of a survey for the assessment of Global and Local Business Partners with established Safety Data Exchange Agreements, monitoring of project progress at global and local level, QC/QA and analysis of the results for the selection of Business Partners to be included in the audit plan.- Management of Business Partner and Service Provider pharmacovigilance audits: establishment of the annual audit plan, preparation of audits in close collaboration with auditors and relevant functions internally and at Business Partner's level, support during audits and follow up of audit outcomes.- Development of a questionnaire for the assessment of Business Partner's pharmacovigilance system.Management of internal pharmacovigilance process audits and Business Partner audits hosted by Sanofi: - Audit preparation- Support during auditsBackroom management during EMA/ANSM pharmacovigilance inspection.

Paris, France, Fr

Clinical studies and post-marketing pharmacovigilance-related activities for Praluent (ALIROCUMAB): case review and quality, signal detection, literature review and periodic safety reports.Management of Data Monitoring Committee preparation and coordination of case review by external subject matter experts.

Paris, France, Fr

Interpretation of Safety Regulatory information to determine the value of the knowledge contained therein and how it should be applied to proactively maintain compliance: - Support the QPPV office in developing strategies, policy and processes for implementation of new safety regulatory documents into the quality system - Provide safety regulatory analysis of international, regional and national pharmacovigilance requirements​ ​- Participate in internal transversal collaborative groups organized to implement regulatory changes within Sanofi (GVP of Arab countries, GVP of Eurasian countries) - Communicate internally on new regulation​ from the main Health Authorities or Organisation such as EMA, FDA, Health Canada or ICHSetup of a SharePoint on Safety Regulatory requirements allowing a faster and easier way to inform and exchange with PV Affiliates and other members of the Pharmacovigilance Team within Sanofi Headquarter.

Suresnes, Fr

Within the Neuropsychiatric Therapeutic Area Team working mainly on Tianeptine and Piribedil:- Signal management- Periodic Safety Reports (PBRER/PSUR, DSUR, internal periodic reports for the review of product’s safety profil)- Case review and quality

Project: « Retrospective study of anti-tuberculosis treatments tolerance in the Hospital of Rennes from January 2000 to August 2013 »Identification and reporting of adverse events in patients under anti-tuberculosis treatment from the infectious diseases unit and the intensive care unit.Registration of adverse events in the national database of pharmacovigilance.

Missions: - Set up of clinical trials (endocrinology, pediatric, oncology) - Stock management and Investigational drug delivery

Project: The use of the Vivascope® system (confocal laser scanner microscopy) associated with the FLIM (Fluorescence Lifetime Imaging Microscopy) to study ex vivo and in vivo skin permeation.

Missions:- Information to patients for the use of their insulin treatment and how to adapt treatment dosage. - Informative presentations about drug therapeutic classes in diabetes.

Employee replacement during school vacations.Drug delivery, patient intake and stock management.

Bachelor Of Pharmacy (B.Pharm.), Pharmacie

Eudipharm Master'S Degree, Engineering For Health And Drugs, Clinical Assessment Specialization

French High School Graduation Diploma, Sciences Division, Physic And Chemistry Specialty