Therapeutic areas of experience:
Drug Safety Consulting 2003 - Present
- VP of company providing information and data on drug safety and use.
- Company has provided consultation services to many pharmaceutical companies such as Otsuka, Johnson & Johnson, Pfizer, small pharma sand CROs.
Previous Drug Safety Experience
- Director and head of clinical research for a large private practice and clinical research center 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.
- Relocated to the US in 1998 and since then worked as global medical director drug safety for pharmaceutical companies including Eli Lilly and Aventis.
- Let a team of Physician experts and associates in bringing quality service to the pharmaceutical industry with over 40 years' combined physician experience.
- Combines a broad, global and local knowledge of the pharmaceutical business with deliverables, designed to meet the needs of clients.
Research Experience, Clinical Development, Medical Affairs
- As senior drug safety expert and director, directs global pharmacovigilance and drug safety activities for assigned products of over 300 drugs for several clients. In charge of writing and reviewing all company product safety update reports globally, and responding to all regulatory issues dealing with drug safety.
- Global safety/regulatory affairs expert responding to worldwide queries from regulatory authorities and affiliates of over 100 countries.
- Review of prospective drug candidates for INDs and clinical development opportunities for NDAs.
- Clinical safety monitor for clinical trials, evaluating safety reports and reviewing for signals. Writes and reviews protocols for clinical trials.
- Determines risk assessment and safety profile of new drug products.
- Review of company labels for drug portfolio for consistency with pertinent safety information.
- Support Sales and Marketing personnel on field for safety issues.
- Expert consultant for attorneys on interpretation of safety signals and ADRs.
- Clinical research director and medical monitor for phases 1-4 of clinical development and post-marketing.
- Management of CROs for local and global trials.
- Assessment of investigator and site credentials for clinical trials.
- SOP writing and training for safety associates.
- Assisted with setting up pharmacovigilance management plan and systems.
- Assessment of Investigator Initiated Trial proposals for company sponsorship.
- Identified and maintained relationship with expert opinion leaders for input in drug development and post marketing regulatory obligations.
- Member - American Medical Association
M.D., University of Lagos, College of Medicine
- Completed Board Certification in Pediatrics and Family Practice