Medical Doctor Consultant Specializing in Drug Safety (1341)
Expertise
Professional areas of expertise:
Drug safety and surveillance for the pharmaceutical industry.
Drug safety communications and pharma company vigilance.
Reviews of drug IND and NDA.
Review drug labeling and compliance with safety information and FDA regulations.
Therapeutic areas of expertise:
Pain and pain management.
Neurology.
Cardiovascular pharmaceutical and therapies.
Women's health.
Metabolism and pharmaceutical and therapies.
Experience
Vice President, Independent Consulting Firm 2003 - Current
Co-founder of consulting practice to meet unmet medical needs in the pharmaceutical industry. The company has provided on going consultation services to many pharmaceutical companies.
Previous Background
Conducted both clinical practice and research in San Fernando Trinidad, directing regional phase III-IV clinical trials and post marketing ADR evaluation mainly on Cardiovascular, endocrine/metabolism, anti-infective and dermatological products.
Worked in the US for the last 10 years as medical director drug safety for pharmaceutical companies including Johnson & Johnson, Eli Lilly and Teva.
Management experience over the years has included hiring, training staff, performance management and development. Responsible for setting business goals for the departments she manages which have included up to 30 member staff, with local, regional and international locations.
Combines a broad, global and local knowledge of the pharmaceutical business with deliverables, designed to meet the needs of prospective clients.
Research Experience: Clinical Development and Drug Safety.
Directs pharmacovigilance and drug safety activities for the North American region for several clients. In charge of writing and reviewing all company product safety update reports for the USA, and responding to all regulatory issues dealing with drug safety. Product portfolio is over 200 drugs.
Reviews prospective drug candidates for INDs and clinical development opportunities for NDAs.
Medical monitor for clinical trials, North American region, responding to investigator and site questions on clinical matters.
Reviews client company labels for drug portfolio for consistency with pertinent safety information.
Has supervised several regulatory authority audits in the past.
Adviser to legal counsel on safety process and interpretation of ADRs, signals and causality relationship.
Consultant regulatory affairs, developing regulatory response strategies to authorities worldwide.
Education
M.D., College of Medicine, University of Lagos
Completed Board certification in OB & GYN and Family practice.