Ligia Scarpa Vilar
Global Drug Safety Officer @Laboratoires Pierre Fabre
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WORK HISTORY
Global Drug Safety Officer @Laboratoires Pierre Fabre
Boulogne-Billancourt, FR
Review and evaluate safety data (risk-benefit assessment) of assigned products- Provide scientific input for PBRERs, DSURs and safety aspects of regulatory authority submission documents; Writing of safety sections of CDS/RMP updates- Represent Patient Safety on cross-functional project teams.
EDUCATION
Universidade Estadual Paulista Júlio de Mesquita Filho
Doctor of Pharmacy - PharmD, Farmácia-Bioquímica
ABOUT LIGIA SCARPA VILAR
Pharmacist with over 10 years of extensive cross-functional experience in Pharmacovigilance and Clinical Research. Multifaceted background and proven communication and flexibility skills allowing to adapt and to integrate into a multidisciplinary team. I am able manage several tasks by working independently and within strict deadlines- Solid experience in the complete range of Pharmacovigilance processes: Medical writing of aggregate reports, risk management, compliance and ICSR handling- Advanced knowledge of clinical trials from Phase I-IV with regards of regulatory requirements and safety data- Strong knowledge of GVP, ICH-GCP and both EU and Latin America legislations- Proficient user of Argus, MedDRA, EDC, CTMS, eTMF
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