Reports to : Associate Director, Drug Safety.
• Supports Case Management team with all pharmacovigilance activities associated with Individual Case Safety Report (ICSR) processing and reporting of adverse events in accordance with local regulations and company procedures.
• Accountable for mentoring, coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development.
• Responsible for the performance of assigned personnel against departmental processes, standards and performance goals and for ensuring successful completion of all training required for the role.
• Author and review updates and new documents, processes or activities to create unified and consistent safety-related procedures within the department.
• Demonstrates seamless collaboration with other departments for delivery of drug safety services, process improvement initiatives and to provide guidance for cross-functional team activities.
• Assist with the preparation of safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, IND annual reports, integrated summaries of safety).
• Provide general oversight to the management of outsourced data collection activities with CRO’s and lead preparation, review and approval of new or updated documentation to support standardizing outsourced activities (e.g. safety management plans and budgets).
• Under the guidance of the manager will collaborate with corporate partners for clinical trial and post-marketing pharmacovigilance activities (i.e. pharmacovigilance agreements).
• Contribute to the development and implementation of the strategic direction for case management functional team and department.
• Detail oriented with the ability and desire to work in a fast paced, team oriented small company environment with the ability to manage simultaneous priorities and challenging deadlines.
• Demonstrated knowledge of domestic and international regulatory safety reporting requirements. Must have excellent, concise writing skills.
• Experience with the use of drug safety databases (e.g., Argus, ARISg, etc.).
• BS Pharmacy, PharmD, BS RN degree with critical care management background preferred, MD or equivalent training.
• Six years’ experience in Drug Safety in a biopharmaceutical environment is preferred.
• Previous management experience preferred.
Seattle Genetics is an equal opportunity employer.
Seattle Genetics - 13 months ago