Neda Chamova
Senior Principal Safety Scientist, Pharmacovigilance Specialised Services, Operational Delivery at Icon Plc
Based in Lozenets, Bulgaria
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Seniority
Director
Department
Science
Location
Lozenets
Industry
Biotechnology Research
Company size
35K
Contact information
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n•••••••@iconplc.com
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Background
About Neda Chamova
I hold a master’s degree in Pharmacy from the Medical University of Sofia, Bulgaria and a postgraduate specialty in Pharmacology and Pharmacotherapy from the same university. I have a 9+ year experience in Pharmacovigilance & Patient Safety (which includes pre, peri-approval and post-marketing safety). For 3 years, as a Drug Safety Specialist, I was involved in Individual Case Safety Report (ICSR) management and Signal Detection activities for multiple products. For 2 years, as a Senior Drug Safety Specialist, I served as a Product Safety Expert for numerous medicinal products where I conducted the Safety Signal and Risk Management activities related to these products. For the last 4+ years, as a Safety Scientist, I have been acting as a PV consultant, providing strategic input and recommendation related to Case Processing, Medical Review, Safety Surveillance, Risk Management, Benefit-Risk evaluation and regulatory compliance/inspection readiness. My primary responsibilities include but are not limited to the generation of client-owned global controlled documents (SOPs, WIs, Templates), regulatory response documents, planning and generation of Risk Management Plans (RMPs) and associated Pharmacovigilance activities and Risk Minimization Measures, including oversight of commitments tracking and evaluation of effectiveness of additional Risk Minimization Measures (aRMMs). I am result- and detail-oriented, yet pragmatic in my work with strong critical, problem-solving thinking and demonstrated proficiency in client focus and relationship management.
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