los angeles, CA30+ days ago
Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturingOversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agenciesResponsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate)Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluationResponsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research dataProvides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needsOversees development and preparation of Risk Management Actions Plans for regulatory filingsSupports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirementsWorks with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activitiesAccountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications: Education: Medical Degree (MD or DO), and current medical license preferredBoard Certification or equivalent in a medical specialty and significant clinical experienceProfessional Experience:Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functionsMinimum of 5 years' management experience leading a drug safety group in the pharmaceutical industryExtensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plansPost-graduate training in clinical epidemiology and biostatistics is also desirableAbility to travel domestically & internationally as required, typically up to 30%Knowledge and Skills:Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organizationThorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines)Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g.