Pharmacy-Safety and Clinical Research Specialist

Judith M. Muratore

***** ******* **** ***** ***********, VA 20120

Phone: 978-***-****

************@*****.***

SUMMARY

A resourceful and creative administrator and enabler of all phases of medical research and data analysis projects. Supervisory experience in recruiting study patients, coordinating and managing activities of clinical research projects, and overseeing completion and accuracy of data collection. Pharmacovigilance experience including all phases of serious adverse event case processing narrative writing, and submission to worldwide regulatory agencies.

EXPERIENCE

Oct 2017-JAN 2023

DRUG SAFETY SPECIALIST

HealthCore [previously New England Research Institutes]-Watertown, MA

Responsible for the review, evaluation and management of adverse event reports in accordance with FDA, EMEA, other applicable health authorities and ICH guidelines and regulations.

• Manage safety vendor to ensure timely AE case entry, processing, notification to business partners, and expedited report submission and tracking.

• Perform quality check on AE reports.

• Perform AE/SAE reconciliations.

• Coordinate and facilitate the review of AE/SAEs with medical personnel to assure timely assessment of cases.

• Act as Drug Safety representative for assigned studies and for all safety related activities including participation in the review of study protocols and amendments, case report forms, safety management plans, clinical study reports, ad-hoc safety reports, investigator brochures, annual reports, data management plans, clinical data review plans, data listing reviews, and all other study documents or activities requiring safety review and input.

• Ensure compliance with local and international reporting of adverse events throughout the program including reporting to Competent Authorities, Ethics Committees, Institutional Review Boards, Investigators, and other manufacturers’.

• Facilitate the analysis of similar events and/or risk benefit statement for expedited safety reports occurring in clinical studies.

• Perform monthly review of SAE data/listings for assigned studies.

Jan 2017-February 2017

DRUG SAFETY SPECIALIST

Karyopharm Therapeutics- Newton, MA

Search Pharmacovigilance inbox for relative source records for legacy SAE case reports

Review source documentation for SAEs reported from Clinical Trials, ISTs, and Compassionate Use

Upload source documents to VEEVA in-house content management database

Nov 2014-MAY 2015

DRUG SAFETY ASSOCIATE

Radius Health-Waltham, MA

Responsible for operations oversight for Phase III clinical trial case narrative creation and completion for clinical database lock.

Organize and liaise between sponsor, CRO, outside vendors, internal medical staff for timely creation and review of medical case narratives to be used for FDA NDA application.

March 2013-MAY 2014

PHARMACOVIGILANCE ANALYST III

Alexion Pharmaceuticals-Cambridge, MA

•Responsible for global submission for serious and non-serious individual case health reports

•Ensure compliance with global health authority regulations in regard to

• drug safety data processing and reporting

•Interact with regulatory affairs on case submission related issues

•Responsible for training external vendors on Alexion global submission processes

May 2011-February 2013

SENIOR DRUG SAFETY SPECIALIST

Genzyme Corporation- Cambridge, MA

Receive and process adverse events, preparing the report for submission to the appropriate authorities and/or agencies.

Ensure all reporting documentation is complete, following up on incomplete information, and accurately capturing the receipt of all information into ARGUS safety database.

Identify and alert management and other groups as soon as a trend is recognized.

Provide safety expertise on assigned products including sending out and answering telephone and written inquiries.

Participate on cross-functional project teams including representing Global Patient Safety to ensure accuracy and compliance with domestic and international regulatory requirements.

Mar 2010-May 2011

DRUG SAFETY ASSOCIATE

AMAG Pharmaceuticals, Inc., Lexington, MA

Perform intake and data entry of adverse event reports from clinical trials and post-marketing surveillance per the company SOPs

Data is entered into secure ARGUS database including the creation of case narrative reports

Assist with preparing drug safety/Pharmacovigilance documents as requested

Support safety surveillance activities in clinical trials and post-marketing surveillance as requested

Assist in quarterly safety reporting to US and worldwide regulatory agencies

Mar 2008-May 2008

MEDICAL CODER

Barry Libman, Inc., Concord, MA

Perform ICD-9 coding on laboratory, radiology, and pathology results for northern New England hospital account.

Researching ICD-9 codes for procedures, and data entering into secure hospital database for medical insurance billing purposes.

Oct 2007-Dec 2007

RESEARCH PROJECT COORDINATOR

Dermatology Partners, Inc., Wellesley, MA

Ruth Tidaldi, M.D. Principal Investigator/Director

•Coordinate and supervise activities of dermatology research protocols.

•Study was postponed indefinitely by FDA due to protocol issues.

1987-1995

PROJECT COORDINATOR

Brigham and Women’s Hospital, Boston, MA

Department of Ophthalmology/Center for Ophthalmic Research

Leo T. Chylack, Jr., M.D., Principal Investigator/Director

•Coordinated and supervised activities of seven research projects, providing administrative support. Served as liaison between the sponsoring organization and pharmaceutical houses.

•Oversaw the completion and accuracy of data collection by the clinical staff, ensuring that each project protocol is being carried out correctly.

•Submitted applications to the monitoring committees for study approval and updates.

•Prepared case report forms (new or revised) and budget as necessary for projects.

•Prepared all clinical data for analysis by the sponsoring organization/pharmaceutical houses, ensuring correct data entry to optimize the database.

•In charge of a new certification/re-certification program, including administration and monitoring of each participating ophthalmologist with monthly reports.

1984-1987

DATA COORDINATOR

Brigham and Women’s Hospital, Boston, MA

Sorbinil Retinopathy Trial/Data Coordinating Center

Charles H. Hennekens, M.D., Principal Investigator

•Responsible for database administration for a feasibility study regarding launch of a major diabetic retinopathy drug by Pfizer Pharmaceutical. Managed study input from 11 national diabetic research clinics. Data were used for analysis by Pfizer and the Food and Drug Administration to determine product marketability.

1982-1984

RESEARCH ASSISTANT

Brigham and Women’s Hospital, Boston, MA

Physician’s Health Study

Charles H. Hennekens, M.D., Principal Investigator

•Responsible for telecommunications system for Harvard Medical School research project involving 25,000 study participants. Managed collection of respondent input used for study analysis. Increased rate of study response through improved interviewing techniques.

PHARMACEUTICALS EXPERIENCE:

Pfizer - Sorbinil

Merck - Lovastatin

Bristol-Myers Squibb - Prevastatin

Hoffman-LaRoche - Antioxidant Vitamin Supplements

AMAG-Feraheme

Genzyme- Devices: Synvisc, Synvisc-One, Epicel, Seprafilm.

Drugs: : Hectorol, Renegal, Renvala, MACI, Carticel, Fabrazyme, Myozyme, Lumizyme, Cerezyme.

Alexion-asfotase alfa, Solaris

Radius-abaloparatide

Karyopharm- selinexor

Cordis- Device: INCRAFT Stent Graft System

Novo Nordisk- semaglutide

MEDICAL DEVICE EXPERIENCE:

Genzyme-Synvisc-One

Cordis-INCRAFT

ALN Implants Chirugicaux- ALN Vena Cava Filter

Argon Medical Devices-Option Elite Retrievable Vena Cava Filter

B Braun Interventional Systems-VenaTech LP Vena Cava Filter, VenaTech Convertible Vena Cava Filter

Bard Peripheral Vasular, Inc.-Denali Vena Cava Filter System

Cook Incorporated-Cook Gunther-Tulip Vena Cava Filter System

Cordis- Cordis Optease Retrievable Vena Cava Filter, Cordis Optease Permanent Vena Cava Filter

Jarvik-Jarvik 2015 Ventrical Assist Device

XELTIS-Bioabsorbable pulmonary valved conduit

EDUCATION:

Boston University, Bachelor of Arts, Sociology

COMPUTER SKILLS/OTHER:

ARGUS Safety Database, Merge EDC, IBM EClinicalOS, EDC, DATATRAK, iMedNet, Veeva, Sharepoint, ICD-9 Coding, WHOdrug, MedDRA Certified April 2022. Expertise on worldwide regulatory adverse event reporting and regulations.

Contact this candidate