Sr. Director, Pharmacovigilance Operations Job in Tarrytown 10591, New York Us
Job Description:
· Oversee and manage activities of the Pharmacovigilance (PV) Operations group, including case processing, aggregate reporting and safety systems. Oversee, with final responsibility for collection, processing and reporting of serious adverse events from clinical trials and for all postmarketing adverse events in accordance with FDA/ICH regulations, and Regeneron SOPs and Working Practices.
· Maintain knowledge of and compliance with all US and international regulations governing serious and non-serious adverse event reporting. Responsible for oversight and management of PV Operations staff, including quality standards, adequacy of training, job performance and career development.
· Acts as liaison with corporate partners for safety reporting for jointly managed clinical trials
· Represent PV Operations at internal and external meetings. Responsible for all PV Operations deliverables.
· 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.
· Responsible for all PV Operations deliverables.
Requirements:
· Requires health care professional degree; advanced degree preferred.
· A minimum of 10 years of experience in clinical trial and postmarketing adverse event processing and submission.
· Team leadership experience and a minimum of 4 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
· We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
EOE/M/F/D/V
Disclaimer: Effective immediately, Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com
Apply online at: https://sh.webhire.com/servlet/av/jd?ai=874ji=2585445sn=I
Company description:
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, manufacturers, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, which is approved for the treatment of a rare inflammatory condition, Regeneron has completed Phase 3 clinical trials of rilonacept for a new indication and of product candidates EYLEA (aflibercept injection; VEGF Trap Eye) in diseases of the eye and ZALTRAP (aflibercept) (VEGF Trap) in colorectal cancer. EYLEA is currently under review with U.S. and European regulatory authorities. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis, pain, cholesterol reduction, allergic and immune conditions, and cancer.