Viktor Patskan

Experience

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  TCS/Roche Drug Safety Physician

  Feb 2013 - Jan 2016

  Drug Safety Operations Physician

  Led Global Drug Safety for 2 chemotherapeutic compounds (one in pre-approval stage)Trained and mentored 2 new Safety Physicians and many drug safety team Safety Scientists Lead the process to improve standardization, speed and quality of Suspected Unexpected Serious Adverse Reactions (SUSARs) narrativesDelivered safety contribution to FDA and EMA 7 and 15 day SUSAR submissions in collaboration with project stakeholders to ensure timely responses to global SAE and SUSAR safety queriesEnsured medical completeness and clarity of Adverse Event Reports for oncology, immunology, ophthalmology and respiratory therapy area consistent with DSURs, IND Annual Reports, Investigator BrochuresRepresented Drug Safety in internal and external Pharmacovigilance auditsDeveloped close working relationships with Safety Science Groups increasing awareness of critical AEsPerformed signal detection, evaluation and validation, including review of relevant medical/scientific literatureExpert user of ARISg Safety Database Show less

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  Sanofi Pasteur

  Jan 2016 - now

  Medical Director, GSO

  Responsible for detecting, evaluating and characterizing a global product portfolio safety profile in order to guarantee the relevance and the quality of information on the safety data. Pharmacovigilance/subject matter expert for assigned product franchise for internal needs & external regulatory authorities or health professional team activities. Responsible for the interaction with the FDA in the United States on safety issues. Providing the highest quality support and contribute pharmacovigilance expertise to major international projects, development of the new advanced vaccine formulation and others. Maintenance and analysis of the vaccine pregnancy registries.Global safety expert responsible for continuous monitoring of safety profiles, detection and investigation of safety signals, and evaluation of the benefit-risk ratio of Sanofi Pasteur products: • Pharmacovigilance lead evaluating potential in-licensing opportunities• Lead cross functional Safety Management Teams (SMTs) and Safety Evaluation Teams (SETs)• Pharmacovigilance lead supporting interactions with eternal partners, key opinion leaders, Health Authorities responses to queries and marketing company launches• Global Safety Medical signatory for Investigator Brochures, Periodic Benefit Risk Evaluation Reports (PBRERs).• Pharmacovigilance team member on project/product teams providing input to labeling and Investigator Sponsored Studies (ISS).• Trained and approved to work with Biomedical Advanced Research & Development Authority (BARDA).• Expert user of Safety Databases AWARE and ARGUS, and Medidata and RAVE Software. Show less