- 15+ years in pharmacovigilance.
International Pharmacovigiliance (Phases I-IV); Medical Specialties: Cardiovascular, Dermatology, Endocrinology, Gynecology, Hematology, Neurology, and Oncology; EDC Specialties: ARISg Safety System, DataFax, DATATRAK (Data System Blinded), Medidata Rave, and OmniComm; BSN/Registered Nurse.
Associate Director of Pharmacovigilance, Pharm–Olam
Overall responsibility for and management of clinical and post-marketing functions, ensuring all are delivered to a high quality and with medical/clinical integrity. Work with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies are in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP). Advise and assure investigators, project teams, and clients on safety issues arising from medicinal products, devices, and study designs undertaken by POI. Review SAEs, SUSARs, and AEs and write safety narratives in accordance with all applicable competent authority regulations and ICH E2 reporting standards. Work with internal team members, senior management, and business development on issues and questions of medical safety nature.
Senior Manager Drug Safety, ICON Clinical Research, Inc.
Ensured the efficient daily operations of assigned projects within the department, in alignment with contracted agreements. Completed all activities accurately in accordance with ICON standards, Sponsor requirements, and applicable regulations. Provided direct line-supervision of project staff including development of skills and evaluations. Provided upper management with updates on project activities, including issue escalation, as well as on staff member progress, as required. Supported the proposal process and developed costs and presentations.
Drug Safety Manager, ICON Clinical Research, Inc.
Principal Drug Safety Associate, ICON Clinical Research, Inc.
Senior Drug Safety Associate, ICON Clinical Research, Inc.
Drug Safety Associate, ICON Clinical Research, Inc.