Dr. Linet Bolar is a physician with more than 10 years of combined pharma and device vigilance, academic research, scientific writing, and clinical research experience. She has a sound knowledge of human pathophysiology and disease, a familiarity with common safety databases and EDC systems as well as product launch experience. Additionally, she has worked with regulatory authorities such as FDA and has extensive experience in the development of Clinical Study Protocols, Investigator’s Brochures, Safety Analysis Plans, DMC Charters, Expedited Reports, Clinical Evaluation Reports, Annual Progress Reports and Clinical Study Reports in compliance with regulatory requirements.
Prior to joining FHA, Dr. Bolar spent time in roles of increasing responsibility in PV as Regional Head of Medical Safety and Medical Product Information. In this capacity, she was responsible for the implementation, alignment, and oversight of vigilance systems and process in the North America region. Previous to this role, she was the Head of Safety Evaluation and Risk Management for the surgical portfolio of products with the overall responsibility for safety evaluation and benefit-risk management of all marketed and investigational surgical products including signal detection and trend analysis.
Dr. Bolar has significant experience leading safety teams and surveillance initiatives to facilitate the strategic and operational oversight of the management of evolving safety issues. Additionally, Dr. Bolar has supported the evaluation of external technologies for business development and acquisition.