About the position
Responsibilities
• 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.
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