Manager/Senior Manager, Pharmacovigilance

Company: Epizyme
Location: Somerville
Posted on: October 8, 2020

Job Description:

DescriptionJob Title: Manager/Senior Manager, PharmacovigilanceEpizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit .Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  The Manager/Senior Manager Pharmacovigilance oversees junior personnel and develops and maintains the necessary processes to ensure high quality clinical trial individual case and aggregate safety reporting. S/he supports the pharmacovigilance needs of the company. A reliable team player that has the ability to work well vertically and cross functionally with regulatory affairs, QA, medical, clinical science, data management and clinical operations.Key Responsibilities: Oversees and mentors PV specialists responsible for clinical trial SAE processing and reporting Ensures product risk information is used consistently across studies using the same IMPMentors PV specialists in their review of safety sections of protocols, ICF risk text.Ensures adequate PV resource to meet study SAE processing needs, are available to meet upcoming PV deliverables; supports PV by acting as individual contributor when neededMonitors safety vendors to ensure compliance to management plans and routine report delivery/accuracyEvaluates current, and implements approved, PV process/system improvementsIn collaboration with PV management, participates in the review of safety data exchange agreements, Investigator Sponsored trial contracts, etc.Ensures ICSR submission compliance with applicable domestic and international regulationsDevelop, review and maintain pharmacovigilance Standard Operating Procedures.Work closely with Head of PV on aggregate reports (DSUR, 6mosLL, Annual study updates, etc.)Support development of RMPs for products slated for EU market authorizationEducation & Requirements:Bachelor’s degree in science preferred; advanced degree, BSN, MPH, NP, PA, PharmD, preferredAt least 5 years in pharmacovigilance operations including hands on case processing experience in clinical studies and management of operational personnel; post marketing experience a plusKnowledge of drug development, detailed knowledge of both US and Ex-US regulatory safety requirementsProven ability to manage, mentor individual contributors of varying education and/or experienceOncology case processing preferredAbility to meet strict timelines under pressure and changing priorities related to safety of clinical trial patientsExcellent communication and interpersonal skills Proficient with and ability to utilize WORD, Excel, Adobe Acrobat, and safety databasesEpizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.Hiring Manager Approval:Print NameSignatureDate (ex. January 1, 2018)Department Leader Approval:Print NameSignatureDate (ex. January 1, 2018)Template: TMP-00031 Version 1.0 Page 1 of 2

Keywords: Epizyme, Somerville , Manager/Senior Manager, Pharmacovigilance, Other , Somerville, Massachusetts