I am a Senior Drug Safety professional, board-certified in Ob-Gyne with 20 plus years career in the pharmaceutical/biotech industry. Experience with phase I - III clinical trials and post-market drug safety in US and international setting. Created full-service, compliant Drug Safety department beginning from phase III through approval and post-market surveillance (various therapeutic area targeted therapy). Experience with alliance partnerships, vendor management, distributor and safety data exchange agreements. Author/reviewer of safety content for patient informed consent, clinical study protocol, investigator brochure, integrated safety summary, individual case safety narratives in addition to periodic reports. Implemented in-house and hosted safety database models. Therapeutic areas include: medical device, pharmaceutical, neurology, psychiatry, oncology, infectious disease, cardiology and etc. Through the years I have accumulated skills and experience working in different departments (Clinical Operations, Medical Affairs and PV and Drug Safety). Recently I have gone through several audits internal and external with my current company. I have gained a lot of experience in doing audits and being audited as well. I am passionate about working in clinical research and would like to continue working in this field. I am interested to apply my experience in biotech/pharmaceutical company settings or to explore new areas outside the pharma industry where my drug development background will be relevant.

Highlights:

• Pharmacovigilance
• Drug Safety
• Clinical Research
• Clinical Project Management
• Medical Affairs
• Clinical Development