If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
The Pharmacovigilance Operations Manager has three primary sets of responsibilities:
1) Responsible for all aspects of adverse event processing and reporting for assigned investigational and marketed products in accordance with FDA and international regulations, Regeneron SOPs and Working Practices.
2) Support and/or lead other Pharmacovigilance Operations deliverables such as: preparation of PADERs, line listings and summary tabulations in support of periodic aggregate reports; continuous improvement/quality system initiatives.
3) May be responsible for management of assigned Pharmacovigilance personnel.
Process and distribute all Individual Case Safety Reports (ICSRs) received from any source (clinical trials and post-marketing) in accordance with FDA, international regulations, company SOPs and Working Practices.
This includes but is not limited to:
• Perform initial case assessment for seriousness and expectedness/listedness;
• Ensure proper coding of events;
• Evaluate and assess incoming ICSR and source documentation for completeness, accuracy, legibility, and consistency of information;
• Determine necessary follow-up requests;
• Ensure proper distribution and submission of expedited and non-expedited ICSRs to regulatory authorities, partner companies, others as needed;
• Ensure Investigator Letters are processed and distributed according to regulatory timelines;
• Ensure compliance with regulatory, partner companies and company timelines;
• Collaborate with Clinical Teams, CROs and License Partners to ensure proper management of adverse event processing and reporting in accordance with applicable regulations, Pharmacovigilance Agreement/Safety Data Exchange, Regeneron SOPs and WPs;
• For assigned products, support of Clinical Teams and CROs includes but is not limited to study start up activities, Safety Monitoring Plans, Patient Safety Narratives, data reconciliation with Data Management and Partners when applicable;
• Responsible for the process to accurately and timely prepare PADERs, line listings and summary tabulations in support of aggregate periodic reports;
• Lead and contribute to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies;
• Ensure development and maintenance of applicable SOPs and Working Practices and training;
• Responsible for all aspects of management of assigned Pharmacovigilance personnel. This includes but is not limited to management of job performance, career development, and training;
• Assume significant responsibility in preparation and support of audits and inspections. Demonstrate independent problem solving ability and leadership skills in executing tasks;
• Represent PV Operations at internal and external meetings;
• Maintain knowledge of US and international regulations regarding adverse event reporting.
• Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent required, advanced degree preferred.
• Previous safety or clinical experience in the pharmaceutical industry required; 10+ years (8+ years if Master’s Degree) of Pharmacovigilance/Drug Safety experience required;
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required;
• Experience with and demonstrated success in working on cross-functional diverse teams required;
• Demonstrated leadership of projects or teams required;
• Excellent negotiation, conflict resolution, decision making, problem solving skills;
• Experience in working with software-based Pharmacovigilance systems required;
• Ability to work under strict deadlines and changing priorities with minimal supervision;
• Good written and verbal communication skills;
• Strong organizational and problem-solving skills;
• Strong interpersonal skills and professionalism required;
• Demonstrate initiative, seek ways to improve processes and practice;
• Ability to work in a dynamic environment and manage competing priorities.
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.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
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
ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.
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