I am just beginning my journey with Conte Foundation and will update you later. You may reach the Conte Foundation at www.contefoundation.us The end of January 2017, I retired from Novartis clinical safety, where I worked for 17 years, during which time I worked with postmarketing products AND clinical development compounds, including early projects. Therefore, I have knowledge and expertise in clinical safety throughout a compound's life cycle. I have written and supervised the writing of PSURs, ASRs, RMPs, clinical safety sections of NDAs and INDs, clinical safety sections of core data sheets and SPCs. My team and I have successfully submitted 9 NDAs with subsequent approvals. I have also particpated in Health Authority (HA) meetings with the FDA, EMA, French and Canadian HA. Further, I have worked with the FDA during hepatotoxicity and QT/dysrhythmia workshops and well know the external experts in these areas. My scientific expertise is demonstrated by the fact that I was the deputy to the Chief Safety Officer and chair the Novartis safety board in his absence. My favorite is translational and clinical studies to minimize risk.I have a good grasp of cultural differences, since I've worked in companies in France (3 years), Switzerland (6 years), and the US (11 years); I feel these diversities serve to broaden and deepen my working style.Having had an active medical psychiatry practice for 23 years, particularly in-hospital consultation-liaison work, provided an excellent background for understanding the science of clinical drug safety.Specialties: Excellent general clinical safety: regulatory and medical aspects, as well as use of data-mining tools.Special expertise in hepatic and cardiovascular safety issues; conversant with the external experts in these areas.Psychiatry: trauma stress disorder and women's issues.
Listed skills include Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, Clinical Development, and 37 others.
