Vice President, Safety and Pharmacovigilance
Dr. Badri is the Head of Safety and Pharmacovigilance Department at Amarex Clinical Research and has more than 20 years of experience in medical practice and clinical research.
Dr. Badri leads Global Clinical Safety and Pharmacovigilance processes and activities of the Safety and Pharmacovigilance Department, is responsible for management of daily operating procedures for adverse event and serious adverse event reporting, Medical Coding and Medical Monitoring, provides medical and scientific leadership in the Global Development of new medicines for various Therapeutic indications, serves as the organization’s PV subject matter expert and represent Safety and Pharmacovigilance Department during vendors/clients/regulatory agencies meetings and audits such as US FDA audits, leads the review of Safety data and related documents for potential safety issues, the devolvement of Safety Management Plans, Medical Monitoring Plans, and Risk Management Plans and provide strategic leadership for the risk-benefit assessments and signal detection, supports the Biometrics team for aggregating of Safety data for Drug Safety Update Reports, Periodic Safety Reports, IND Annual Reports and signal detection reports, lead narratives preparations for IND Safety reports, annual reports and Clinical Study Reports, provides strategic input for regulatory safety reports, and lead writing Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Periodic Benefit-Risk Evaluations Reports (PBRERs), assists clients with maintaining the Products Safety Profiles/ package inserts/product labels, provide Safety expertise to Clinical Protocols, Informed Consents, Investigator Brochures, Package Inserts, Clinical Study Reports and Integrated Safety Summary Reports, performs literature review as part of post-marketing Safety Surveillance procedures, presents Safety data to Safety Assessment Committees and Data Safety Monitoring Boards and takes a lead role in presenting data and discussing the results, directs Medical Coding activities to ensure data coding is complete and correct based on MedDRA and Global WHO-DRUG coding dictionaries, manages, maintains, and enhances compliance with company Safety and PV Standard Operating Procedures (SOPs).
During her career, Dr. Badri has managed Clinical Safety, Pharmacovigilance, Coding and Medical Monitoring activities of more than 60 Clinical Studies (Phase I-IV) projects, and been involved in writing clinical protocols, clinical study reports (CSRs), annual safety reports, and Case Report Forms (CFRs) for more than 85 clinical trials across a range of therapeutic indications including Cardiovascular, Dermatology, Endocrinology, Gastroenterology, Hematology, Infectious Disease (Sepsis and Septic shock), Nephrology, Neurology, Oncology, Ophthalmology, Pediatrics, Psychiatry, Pulmonology, Urology, Gene Therapy, Pain Management, Critical Care Medicine, Wound Healing (e.g. Diabetic Foot Ulcers and Venous Leg Ulcers), Vaccines, and Rare Diseases.
Dr. Badri earned her Doctor of Medicine (MD degree) in 2002, and is currently enrolled in Master of Public Health (MPH) program at Milken Institute of Public Health, George Washington University in Washington, DC. Before joining Amarex Clinical Research, Dr. Badri worked as postdoctoral research fellow at Harborview Medical Center, University of Washington located in Seattle, WA, and published a peer-reviewed article. Before that, she worked as a physician in rural and urban health centers with a focus on Public Health and Primary Health Care. She has teaching experience and has provided several oral and poster presentations in local and international conferences and published several articles in peer-reviewed journals.