SomervilleRecruiter Since 2001
the smart solution for Somerville jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Surface Warfare Officer
Description: ABOUT America's Navy has the most modern, advanced fleet of ships in the entire world. Surface Warfare Officers SWOs are trained extensively to maintain and operate these ships, their crews and their (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Special Warfare Combatant-Craft Crewmen
Description: ABOUT Special Warfare Combatant-Craft Crewmen SWCC are specially trained to operate on and around rivers and coastal regions around the world. Wielding extreme firepower and a deadly skill set, SWCC (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Military Intelligence
Description: ABOUT Serve at the forefront of national security by analyzing top-secret information and interpreting spy reports. Direct the analysis of top-secret satellite imagery. Be the first to ascertain the (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020


Navy Diver
Description: ABOUT Their accomplishments are epic. Their expertise is unrivaled. No other force is more intensely trained to succeed in the perilous world of underwater adventure. Each assignment they take on is (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Information Professional
Description: ABOUT Effective, secure communication in the cyber domain is essential to the everyday operations of military intelligence in America's Navy. Information Professionals who oversee the seamless operation (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Navy Chaplain
Description: ABOUT The Navy Chaplain Corps boasts more than 800 Navy Chaplains from more than 100 different faith groups, including Christian, Jewish, Muslim, Buddhist and many others. Each Chaplain is also a Navy (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Nursing
Description: ABOUT By the very nature of their duties, Navy Nurses quickly rise to the top of their profession. They provide care, not only for military servicemembers and their families, but also for people in (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Part-Time Food Delivery - Uber Eats
Description: Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends it's up to you. Earn Good Money. You ll earn by bringing (more...)
Company: Uber Eats
Location: East Providence
Posted on: 10/20/2020

Cryptologic Technician
Description: ABOUT Enlisted Sailors in the Navy Cryptology community analyze encrypted electronic communications, jam enemy radar signals, decipher information in foreign languages and maintain state-of-the-art (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Explosive Ordnance Disposal Technician
Description: ABOUT Explosive Ordnance Disposal EOD Technicians have expertise in the most conventional and unconventional explosives to ensure the secure disposal of explosive weaponry. They are on call to respond (more...)
Company: Navy
Location: Woonsocket
Posted on: 10/20/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Somerville RSS job feeds