Dendreon is a fast-paced, high volume production environment. Team building and problem-solving are essential to success in this position.
Dendreon is seeking a Manager of Clinical Safety to contribute to the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications and product labeling/package inserts. This position will work on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors and the ability to exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. General Summary: Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety which may include one or more of the following:*Manages the company´s clinical safety process.*Manages the company´s pharmacovigilance process.*Manages compliance with standard operating procedures.*Develops reports for company management as well as external regulatory agencies.*Contributes to the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications and product labeling/package inserts. Facilitates a multidisciplinary safety committee, which reviews select individual serious adverse event cases and aggregate adverse event data for trends, as well as signal detection summaries from all studies. Facilitates and coordinates Independent Data Monitoring Committees. Prepares presentations, maintains communication as specified in the charters and promptly responds to issues. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements. Provides technical expertise to other departments as part of cross-functional project teams. Contributes to the development of department budget. Selects, develops and evaluates personnel to ensure functional objectives are met. Job Requirements: Bachelors degree as RN/BSN, RPh/PharmD or equivalent. Typically 7 years related experience in cGMP/FDA regulated industry. Typically 3 year´s leadership experience. Some exposure with MedDRA and ArisG is preferred. Proficient in MS Office applications. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.