Manager, PV Planning
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 conduct of safety related activities supporting all stages including late stage clinical compounds in accordance with applicable GCPs and/or regulations. Supports Pharmacovigilance Operations deliverables across compounds including process improvement initiatives. May have management of PV personnel responsibilities. Frequently interacts with collaborators, vendors and/or functional peer group managers. May interact with senior management on matters concerning specific compounds or issues within scope of responsibilities. Interactions normally involve matters between functional areas or collaborations support of clinical programs . interactions with supporting CROs and license partners . Job Duties . Serves as the liaison for internal and external personnel for PV deliverables in clinical programs, generally supports Phase III & IV programs with our without LP . Exercises independent judgment in managing clinical program PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables . Supports and/or leads other Pharmacovigilance Operations deliverables across compounds such as . preparation of line listings and SAE reconciliation listings in support of periodic aggregate reports or clinical studies . Leads and/or contributes to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to PV Ops deliverables whether internal or external to the department . Ensures development and maintenance of applicable SOPs and Working Instructions and training . May be responsible for management of assigned PV personnel . Works on problems of diverse scope in which analysis of situation or data requires evaluation or identifiable factors . Determines and pursue courses of action necessary to obtain desired results . Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions . Collaborates with Clinical Teams, CROs and License Partners to ensure proper management of pharmacovigilance deliverables in clinical programs. May lead a centralized functional activity . Contributes to and supports the completion of organizational projects and goals. Errors in judgment or failure to achieve results require a moderate expenditure of resources to rectify . Requirements . Education . Bachelor's level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred . Experience . Previous safety or clinical experience in the pharmaceutical industry required . 10 + years 8 + years if Master's Degree of Pharmacovigilance/Drug Safety experience required . Demonstrated successful management and completion of a Phase III/IV program s and leadership on projects of equivalent complexity . 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.