Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has evaluated therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.
Responsible for collection, processing and reporting of serious adverse events from clinical trials and for all post marketing adverse events in accordance with FDA/ICH regulations, and Regeneron SOPs and Working Practices. Responsible for all department deliverables and the management of department staff.
Ensure regulatory compliance with all US and international regulations governing serious and non-serious adverse event reporting. Oversee and manage activities of the Pharmacovigilance (PV) Operations group. Responsible for managing assigned PV Operations staff, including quality standards, adequacy of training, job performance and career development
Maintain knowledge of US and international regulations regarding adverse event reporting. Acts as liaison with corporate partners for safety reporting for jointly managed clinical trials
Represent PV Operations at internal and external meetings
Responsible for management of all vendors providing contractual services to PV Operations, including CROs responsible for collection and processing of serious adverse events in Regeneron clinical trials. Oversee development and maintenance of PV Operations SOPs and Working Practices. Oversee maintenance of the electronic ARISg safety database to ensure compliance with regulatory requirements and with all upgrades.
Requires health care professional degree; advanced degree preferred.
A minimum of 7 years of experience in clinical trial and postmarketing adverse event processing and submission.
Team leadership experience and a minimum of 2 years of supervisory experience required. Works independently with all levels of management internally and externally under minimal supervision. Normally receives no instructions on routine work assignments and minimal instructions on project assignments. Expert knowledge of regulations worldwide regarding adverse event reporting.
Advanced knowledge of the ARISg safety database.
Previous significant experience with electronic document management systems and eCTD submissions
Advanced negotiation, management and communications skills a must
Writes and conducts annual performance reviews.
Trains and guides staff in their work assignments.
Typically reports to Executive Director of Pharmacovigilance & Risk Management, or above. Leads and manages department objectives and staff.
Participates in hiring, termination and disciplinary process.