Associate Director, Case Management Vendor Oversight

Management of outsourced vendors to ensure agreed upon KPIs are met. Establish/maintain effective cross-functional team communication to advance quality activities of Alnylam. Support the development of aggregate reports to ensure timely regulatory submission. Education: University degree in biological or natural science or health care discipline required. Experience: A minimum of eight years relevant experience in Patient Safety activities in pharmaceutical industry. Demonstrated ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including advanced understanding and application of medical concepts and terminology). Solid understanding of systems and reporting tools utilized to support pharmacovigilance activities. Demonstrated ability to be highly collaborative and effective in a team environment (including Safety, Clinical Development, Clinical Operations, Biostatistics and Regulatory), as well as with external colleagues for partnered products. Demonstrated ability to lead and mentor personnel. Ability to work independently, with minimal supervision. Excellent written and verbal communication skills. Solid experience in drug development process. Strong expertise in postmarketing pharmacovigilance. Solid understanding of applicable global clinical trial safety regulations and post marketing regulations and experience in participation in regulatory inspections/audits. Clinical judgment, critical thinking, and ability to interpret case information. Strong organizational skills. Experience with overseeing and coordinating work with external vendors. Ability to adapt to a rapidly changing environment. Basic knowledge of common data processing software (e.g. EXCEL, PowerPoint)