SPAbout Sylvie
Medical doctor with more than 20 years of experience in global and local safety, for large pharmaceutical and small biotechnology companies. I supported the registration and development of 50 medications, combination products and devices in oncology, rare diseases, allergy, neurology, and psychiatry.
French
Native or bilingual
English
Fluent
Italian
Fluent
Can work on-site
Paris (up to 50km)
Experience
- IpsenSenior Director Global SafetyPHARMACEUTICALS INDUSTRYFebruary 2021 - June 2024 (3 years and 4 months)Boulogne-Billancourt, FranceFor 1 blockbuster rare diseases and antineoplastic combination product.- Safety asset lead, including new drug application in China, reviewed the 2.7.4, the safety section of the 2.5, wrote a local RMP,- Developed a new device (injection pen),- Oversight of 2 phase III studies and around 50 post-marketing programs PSPs, MRPs, NPPs and ISSs,- Led the development and maintenance of the safety management and risk mitigation plan, updated the core, European and local RMPs,- Oversaw third-party vendors case data entry,- Reported safety trends and concerns within programs and post-marketing setting, detected and analyzed safety signals,- Answered safety-related regulatory authorities’ queries,- Authored safety sections of aggregate safety reports DSURs, PSURs/PBRERs- Wrote PSUR and RMP for the device part of the combination product,- Collaborated a US post-marketing inspection, internal and partners’ audits.Due diligence for oncologic drugs.
- DBV-TechnologiesDirector Global PharmacovigilancePHARMACEUTICALS INDUSTRYOctober 2018 - January 2021 (2 years and 3 months)Montrouge, FranceFor 2 biologic combination products.- Safety expert for a biological marketing authorization in the US and in Europe,- Ensured optimal patient safety in 4 phase II and III clinical trials,- Acting as VP Head of Global Safety and EU QPPV back-up,- Developed SOPs,- Wrote or reviewed safety sections in protocols, CSRs, investigators’ brochures, DSURs, safety review committees meeting, 2.7.4 and 2.5 modules, Q&A and slides for the Advisory Committee, EU RMP and REMS.
- SanofiGlobal Safety PhysicianPHARMACEUTICALS INDUSTRYMay 2006 - September 2018 (12 years and 4 months)Chilly-Mazarin, FranceFor 10 central nervous system and psychiatric drugs including a blockbuster.- Evaluated continuously the products’ benefit-risk profile,- Submitted around 100 signals assessment, that were all approved worldwide,- Proposed risk minimization measures approved worldwide by Health Authorities,- Anticipated, led and resolved several product safety alerts, involving several thousands of cases,- Led working groups on harmonization of safety signal assessment,- Set up an automatized set of biostatistics tables for signal assessment that significantly reduced response time to Health Authorities,- Acted as a signal management expert in audits,- Oversaw outsourced activities,- Recruited, managed, and evaluated 10 PhD trainees.
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Education
- Medical Doctor General PractitionerParis Sorbonne1997Medical Doctor General Practitioner
- National Classification Exam: pass in psychiatry2005National Classification Exam: pass in psychiatry