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.

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.

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.

- 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.

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.

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.

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.

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.

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