I have formed a company to continue my work as a consultant in both the pharmaceutical and medical field.

Head of Department for Clinical Safety and Epidemiology in Ann ArborDepartment included Medical Review of serious adverse events and authoring of investigator letters, review of clinical trial protocols, medical writing of IB, NDA safety sections, FDA correspondence regarding safety issues, author of investigator’s brochure, Epidemiology of both clinical and post-marketing trials, safety database, safety representatives to clinical teams, safety training and Medra coding.Responsible for transition of department from a Warner-Lambert model to a Pfizer model.Global integration of safety and epidemiology of Pfizer and Warner-LambertServed on many therapeutic committees; Cardiovascular, Diabetes, Infectious Disease, Psychiatric, Woman’s health and Neurologic Committee

Roles and ResponsibilitiesReview spontaneous adverse drug events reports and medical literature cases for completeness, accuracy, relevance and assess events for relatedness.Initiate appropriate follow-up and update essential medical information on all reports.Monitored potential safety signals through daily review and weekly surveillance meetingsLiaison with non-US based Lilly Pharmacovigilance sectorsRepresentative from corporate headquarters at a European workshop on methods to facilitate and integrate a global model for Lilly Pharmacovigilance. Presented global communications program.Review regulatory periodic reports submitted to national and international agencies and provide analyses and integrated summaries for these reports.Developing a standard regulatory response document with the Lilly Surveillance team Provide leadership and mentoring for the associates and enhance quality of the reports and competency of the staffLiaison with product teams (compound specific), global affiliates and other functional areas in addressing issues generated by regulatory agencies, legal, media and medical.Member for the cross-functional Issues Management Team (IMT) for Fluoxetine.Played a lead role in re-engineering the roles and responsibilities of Clinical Research Physicians in Pharmacovigilance. Restructured Lilly’s pregnancy registry program

I was a partner and co-founder of Meridian Gynecological Center (MGC) from August, 1992 until August, 1998. This Gynecological office employed 11 individuals in two offices; one is in downtown Indianapolis, Indiana and the other in Moorseville, Indiana associated with Kendrick Memorial Hospital. Meridian Gynecological Center was the only private practice group which actively practiced and had a health care contract with Indiana University. Our practice was self sufficient and did its own billing and contract negotiations. I helped develop and was active in all aspects of operating our practice from the financial aspects to employee development and management. Within three years of establishing MGC, we were free of all debt. Our practice provided all medical and surgical aspects of gynecological care for 8000 patients. I was also an active clinical member and an Associate Professor of the Indiana University training residents and medical students in both obstetrics and gynecology. All of our obstetric patients were delivered at the Indiana University Medical Center. Our practice was the only private practice the residents were exposed during their residencies.I was also Co-Medial Director of the Kendrick Women’s Center. My duties were in assisting in the demographics and market analysis to assess the feasibility and need for this center which includes obstetrics, a service the hospital did not have prior to this endeavor. I assisted with the architectural planning of this new wing of the hospital, recruiting physicians and support personnel. After enjoying a successful private practice career, I chose to leave the clinical practice to pursue opportunities in the pharmaceutical industry. I recruited two physicians to continue in the practice along with my partner.