Temp - Senior Specialist, Case Management
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . Responsible for supporting pharmacovigilance operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements . Responsible for successful conduct of case processing activities for all investigational and marketed products to ensure timely processing of adverse events reports as described in the FDA Code of Federal Regulations, Regeneron Licensing Partners Safety Data Exchange Agreements and SOPs. Supports new/ongoing clinical and post-marketing studies . Job Duties . Essential Functions required for the job. List both technical and managerial requirements if applicable . Interacts with case processing vendor on regular basis to ensure timely processing of adverse events reports for all investigational and marketed products . Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting. Monitors case finalization work stream and prepares reports for distribution . Performs vendor oversight activities by monitoring vendor's case processing quality and compliance metrics . Independently interacts with LPs as needed to support case processing deliverables in accordance with applicable regulations in accordance to license partner agreements . Works closely with medical affairs personnel for PV deliverables related to post-marketing studies/programs . Works closely with Regulatory personnel for regulatory submissions of adverse event reports . Liaise with Medical Information and Commercial leads to manage vendors and personnel directly involved with PV deliverables . Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables . Leads and/or contributes to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to internal PV Ops deliverables . Ensures development and maintenance of applicable SOPs, Working Practices and trainings . Frequently interacts with collaborators, and functional peer groups at various management levels within and outside the organization to support vendor management and case processing deliverables. Interaction typically requires the ability to gain cooperation of others, conducting presentations of PV related information concerning specific projects or schedules . Requirements . Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required . Subject Matter Expert for case processing . Knows when to escalate an issue and has the ability to apply critical thinking if timelines are at risk . Education & Experience . Bachelor's level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred . Previous relevant experience in the pharmaceutical industry required . typically 7+ years with Bachelors degree, 5+ with Masters degree, and 3+ with advanced degree ex. PharmD . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.