Julien Castera
Global Risk Management & Safety Surveillance Rmp & Portfolio Strategist Senior Director @Incyte
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WORK HISTORY
Global Risk Management & Safety Surveillance Rmp & Portfolio Strategist Senior Director @Incyte
FR
Leads a team of Senior Managers for global portfolio management activities (7 direct reports),• Responsible for the Risk Management Plan strategy, development, and execution of efficient Risk management programs worldwide,• Responsible for the strategic leadership of portfolio safety management activities to ensure EU/UK QPPV oversight and compliance with regional regulations (e.g. MAA requirements, Risk Mgt commitments),• In charge of the design and management of Global Safety regulatory intelligence repository with Compliance,• Provides expertise and leadership for the creation and review of Business partner Pharmacovigilance Agreements (PVAs/SDEAs)(+30 ongoing partnerships),• Provides guidance and expertise to the Pre and Post-marketing Pharmacovigilance groups to identify and pursue global and long-term goals for the department,• Supervises and assists global Pharmacovigilance experts with ICSR/SAE processing and reporting activities into Argus, • Develops, review and approve department procedures (e.g. SOPs, Working Instructions), forms and templates, • Acts as Patient Safety point of contact for key Company functions (e.g. Med. Affairs, Clin. Development, Reg. Affairs),• Active participant during audits and inspections (GVP, GCP) and support of relevant functions for CAPA/audit or inspection’s findings investigations,• Part of the Pharmacovigilance Leadership team• Other various activities as Team manager, mentor and trainer.
EDUCATION
Pierre and Marie Curie University
Master's Degree, Neurosciences and new therapies
Université de Bordeaux
Master's Degree, Molecular Biology, Cellular physiology
Université de Bordeaux
Bachelor's Degree, Molecular biology and Physiology
SKILLS
ABOUT JULIEN CASTERA
Committed Pharmacovigilance professional with experience in Pharmaceutical, Biotech and CRO companies (+16 years) including Deputy QPPV experience (2.5 years, from France), strong International Project Management expertise (10 years - certified Project Management Professional [PMP]).Detail-oriented scientist, with a proven ability to perform a broad range of functions efficiently, independently, and accurately in a fast-paced environment. Successfull leader of multi-function teams, recognized for teamwork, clear communication, dedication, and for going the extra mile to get the job done.Special interest in developing and driving high performing teams.Specialties: Pharmacovigilance, QPPV, RMP, Strategy, Project Management (PMP), Drug Safety awareness trainer (ARISg, Argus), Adverse drug reaction Reporting, Quality Control, EU regulatory environment, GCP, Scientific and regulatory aspects of Drug development (both clinical safety and post-marketing), Experience in coding with some of medical dictionaries e.g. MedDRA and WHO-ART, Set-up of new drug safety functions within CRO and small pharmaceutical environments, Triage, Data processing and Assessment of Individual Case Safety Reports.
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