Medical Director Pharmacovigilance, Rare Disease & PDT
About the positionResponsibilities• Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products. • Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. • Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature. • Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.• Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. • Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents. • Provide patient safety input to the clinical development program for assigned products and development compounds. • Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.• Ensure up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure. Requirements• Doctorate in Medicine plus 5 years of related experience. • Prior experience must include utilizing Oracle Empirica for routine signal detection activities and analyzing safety data. • Identify trends and detect new or emerging safety signals from various data sources such as spontaneous adverse event reports, clinical trial data, and literature. • Analyze using statistical methodologies (e.g., disproportionality analysis) within Empirica to assess potential safety concerns.• Evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, and Periodic Adverse Drug Experience Reports. • Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events and WHO DD dictionary coding. • Design and implementation of strategic, operational and personnel development plans as well as training curriculum for assigned Pharmacovigilance associates and specialists. Benefits• Competitive compensation and benefits.Apply tot his job