Clinical Research Safety

MARJORY I. FRASER, RN, BSN, MA, CCRP

E-mail: *******.******@*****.***

Professional Experience

TAKEDA (formerly Shire), Cambridge, MA 25 June 2018-7 Feb 2020

Sr Principal Pharmacovigilance Scientist 9 Dec 2019-7 Feb 2020

Assist with routine and ad hoc safety monitoring activities

Participate in monthly PV/MSD assessment activities (via IVEA for internal cases; external database review via Empirica [FAERS & VIGIBASE]); signal detection; safety analyses; health authority responses

Review/update of CCDS, IB, ICFs, protocols; liaise with CROs in writing of aggregate reports

Represent PV/safety in cross-functional teams in ongoing monthly clinical trial meetings; REMS meetings; clinical sub-team meetings; and committees that have global study or program impact

Conduct literature signaling surveillance monthly via RightFind

Oversight of the development of core, EU, and country-specific risk management plans

Review benefit-risk assessment; update risk tracking document; review of SAE narratives

Set project timelines and initiate quarterly/ad hoc SMT meetings; create slide presentations and receive slide presentations from contributors; compile meeting minutes

Produce cumulative line listings for DMC meeting; extract data from IVEA for Product Quality Complaint annual review

Participate in safety review of SAEs and non-serious AEs for product and reconciliation of clinical and safety databases

Set up product Sharepoint site

Risk Management Lead-Contractor (Beacon Hill Staffing Group, LLC) 25 June 2018-6 Dec 2019

Responsible for the implementation of benefit-risk management for Takeda products.

Develop RMPs, REMS, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory authorities worldwide

Actively participate in Safety Review Team meetings; effectively manage the risk-benefit process, including the Risk Tracking Documents for products

Assists in the management of Risk Management project timelines

Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off

Ensure all regulatory commitments in RMPs are followed and tracked

Represent Risk Management on cross-functional teams and interface with groups, e.g., regulatory affairs, clinical development, business units, as needed

Communicates effectively on product risks to Risk Management Team Lead

Liaise with the Global Safety Leads to improve consistency and accuracy of benefit risk assessment

Critically review and provide medical/safety input of PBRER, RMP, regulatory responses, NDA submissions

Ensure the safety risks with Takeda products are promptly identified

Contribute to ongoing process enhancement for safety surveillance, e.g., developing standard procedures and templates

Outreach to EU LOCs for update on status of additional risk minimization measures (aRMM) educational materials

CELGENE CORP, Summit, NJ July 2016-Oct 2016

SPM Clinical Research Scientist-Contractor (inVentiv Health Clinical)

Monitor Second Primary Malignancy (SPM) events for assigned programs and registries; participate in reconciliation and preparation for Safety Management Committee reviews

Assist the clinical research teams in the development and analysis of safety data trends and events of special interest

Support submission teams with safety section development and review

Write responses/feedback on SPMs and other safety inquiries to clinical team personnel and data managers reviewing SAEs occurring in ongoing oncology clinical trials and registries

Write weekly or monthly reports on new SPMs in ongoing clinical trials and registries

Review of SPM sections for assigned programs or compounds

Provide educational support and expertise to the clinical teams relating to SPM and other risk management strategies

Provide review of ongoing safety summary data including SPM, AE of special interest, and laboratory data

Participate in ad hoc meetings as required by business needs

Lead SPM/safety reconciliation team meetings as required

Prepare or assist with preparation internal presentations

Review SAE narratives and literature and prepare reports on SPM events in assigned programs and registries

Assist VP/Sr Director/Director Global Clinical Projects on special projects as required

In collaboration with the therapeutic area leads, actively participate in the planning and implementation of clinical studies to meet regulatory and clinical research goals

JOHNSON & JOHNSON, Janssen Research & Development, LLC, Horsham, PA Apr 2015-Dec 2015

Pharmacovigilance Scientist-Contractor (inVentiv Health Clinical)

Perform aggregate safety analysis and case level review in Infectious Diseases, Vaccines, Product Safety Intelligence Dept, Global Medical Safety, Pharmacovigilance Evaluation & Reporting

Write standard and special sections of PBRERs (infectious disease, vaccines).

Prepare and coordinate reviews of individual case safety reports as well as aggregate safety data

Author, contribute, and coordinate the preparation of core safety deliverables (Aggregate Reports, Ad Hoc Reports)

Interpret, analyze, and clearly present scientific and technical data in verbal and written format

Ensure timely, quality reports/safety analyses related to core deliverables

Support Risk Management Plans by serving as a coordinator for data acquisition and preparation for review from multiple sources

Collect and/or organize data collected as part of Pharmacovigilance plan, RMP, product recalls, surveillance activities

Manage outsourced data collection, organization, and preparation with vendors as required

Support surveillance activities re: vendors, consultants, and databases

Collate draft reports, progress reports required for updating Health Agencies of RMP activities

Support Physicians, such as case series review, data review, draft reports

Assist in organizing or running searches of safety or regulatory databases

Work closely with management to proactively support TA-related business

Be responsible for product accountability by maintaining product intelligence (ie, creating agendas and documenting decisions, milestones, action items in minutes)

Provide support to related PV activities, e.g., prepare and collate reports for review of product quality data; prepare PowerPoint slide presentations; focused review of special topics for potential safety signals

Deliver innovative solutions for aggregate safety strategy and analyses

Analyze and organize data using Excel pivot tables, SAS JMP

ASTRAZENECA, INC, Wilmington, DE Nov 2013- Mar 2015

Safety Surveillance Scientist-Contractor (Can-Am Consultants, Inc)

Support the work of the Global Safety Physician (GSP)

Set up and develop a Sharepoint site for product-specific and general information for new team members

Collaborate with key stakeholders and programmers on accurate aggregate safety reports

Prepare Core Risk Management Plan (RMP); collaborate with stakeholders to review EU RMP; DSUR; PSSR

Create slide presentations of study data with metrics and analysis of the study results (with special focus on SAEs leading to deaths; pregnancies; patients with renal impairment)

Participate in project team and Safety Surveillance Group meetings under the direction of the GSP

Train new team members (eg, on Text Analytics Surveillance; Knowledge Discovery Platform; SAPPHIRE; Business Objects; Global Electronic Library; Product Knowledge Transfer

Participate in e pre-SERM review; prepare/assist in preparation of SERM discussion documents for the GSP

Obtain accurate data for signal evaluation/ review; analyze study data from SAPPHIRE and Business Objects reports

Review patient level data (AEs and SAEs) across ~13 ongoing clinical studies (phase I-III); also review and provide feedback on SAE narratives written by CROs

Provide safety summary of clinical trial data at the monthly Safety Management Team (SaMT) meetings; prepare draft minutes; distribute final SaMT meeting minutes; store them in PKT safety surveillance library

Analyze safety data on clinical trials with the GSP monthly using Safety Management System (SMS); submit patient data queries to CROs

Conduct the review, evaluate and store the results of routine literature searches of published scientific and medical literature monthly for signals related to the product; use of TAS and KDP(MIS) alerts for review of scientific meeting abstracts; share relevant data with the GSP; prepare Excel spreadsheet reports on results of focused literature searches (eg, on status epilepticus, seizures, convulsions, and other ADRs using the Embase.com and KDP databases)

NOVO NORDISK, Princeton, NJ

Site Specialist/Medical Reviewer- Contractor in- Contractor (inVentiv Health Clinical SRE, LLC) July-Sept 2013

Review titration levels/titration management within diabetes patients using insulin.

Monitor live data from clinical research sites to review patients’ blood glucose levels to ensure sites are regulating insulin levels according to the study protocol.

Contact investigators to discuss their rationale regarding titration of study medication (eg, for patients with hypoglycemia) and documentation of SAEs in global diabetes research studies.

MERCK & CO, INC, North Wales, PA Nov 2012 –July 2013

Clinical Risk Management Scientist- Contractor (Joulé Clinical & Scientific Staffing Solutions)

Write safety sections of aggregate reports (in RCAM using ISI Writer); post-marketing reports in PBRER/PSURs; Addendum Reports (for statin combination products); AERs; NDA (eg, NDA submission of statin combination product Liptruzet for rest of world).Identify and clinically interpret safety signals; perform safety surveillance review of serious adverse event (SAE) reports in post-marketed products (eg, diabetes medications Januvia and Janumet) and statin combination products.

Request aggregate listings (output from MARRS) to support aggregate safety data review/ summary of aggregate data.

Review label validation file of expected (labeled) terms for a product.

Review SAE reports/CIOMs containing assigned terms for AER for post-marketed diabetes products (eg, for serious/nonserious reports, positive re-challenges, serious/nonserious labs, confounding variables).

Review abstracts/articles/reports on relevant safety topics (eg, relating to specific post-marketed products).

Participate in development/evaluation of pharmacovigilance and risk management plan for statin post-marketed products.

Prepare responses to inquiries from health professionals and regulatory agencies regarding SAEs in diabetes post-marketed products.

PFIZER, INC, Collegeville, PA May 2009 –Mar 2012

Clinician – Contractor (inVentiv Health Clinical)

Responsible for working collaboratively with the clinical leader physicians and members of the development team to establish the key components of the clinical protocol and clinical development plan/s for a compound in a global Phase I/II Multiple Ascending Dose, Proof-of-Concept Rheumatoid Arthritis study and the Open-Label Extension Study.

Primary Duties:

Write or contribute to phase I/II protocol and open label extension study protocol; write protocol amendments.

Prepare Risk/Benefit comparison, write updates to ICF and safety section of investigator brochure.

Perform regular review of individual subject safety data and cumulative safety data with a physician consistent with the safety review plan; review clinical data for safety signals; obtain opinion of key opinion leaders relating to safety signals.

Attend Safety Review & Risk Management Committee meetings; present new SAEs and AEs of interest.

Write narratives for SAEs and AEs of Interest; also review/provide feedback on narratives written by CRO.

Collaborate with Safety Manager and Data Management to reconcile safety and patient databases.

Write monthly report and conduct monthly review of protocol deviations (PD) and PD metrics for global study; chair PD review meetings; act as clinical representative in due diligence reviews and internal audits.

Contribute to team response to queries from institutional review boards and regulatory bodies regarding the SAEs, protocol, and informed consent form; maintain Excel file of team responses to queries.

Serve as primary contact with safety group, internal governance, regulatory, project team members and also external investigators and monitors to provide study level medical and scientific support and resolution of study-related issues.

Create protocol training materials for investigators and monitors; publish monthly newsletter to be sent to research sites.

Participate in analysis and design process, data listings, data review plan, case report form design, clinical data presentation plan review, and review of clinical study report.

Drive creator team WebEx meetings to develop data lifecycle package for new medical assessment tool for rheumatoid arthritis; schedule, facilitate, oversee meetings; track and respond to reviewers’ comments.

ASTRAZENECA, INC, Wilmington, DE Apr 2007-Mar 2009

Clinical Research Scientist-ERP/Site Manager-Contractor (ABOUT-Consulting, LLC)

Manage US sites for Cardiovascular Phase III study.

Respond promptly to e-mails from the Study SAE website and phone calls from the Study Call Center; ensure essential information on SAEs is complete; follow up promptly with sites to obtain missing information.

Communicate with US sites and regional monitors to obtain data for study endpoints and SAEs and study master file documents; troubleshoot and decrease site open queries in electronic data capture system.

Experience with Medidata Rave electronic data capture system, Clinical Partners Portal-EMIL, Study Master File, IMPACT, data edit checks, IVRS-IWRS, study E-room.

Clinical Research Scientist-ERP/Study Delivery Operations Specialist-Contractor

Write narratives on suicidality, SAEs, AEs, events of special interest in clinical studies on antipsychotic medication.

Write patient narratives with data taken from multiple sources for studies involving cross-functional collaboration with Study Delivery, Patient Safety, Statistical Programming, and Regulatory to support requests from the FDA.

Perform a safety related investigation into the extent of an expired medication problem and related SAEs.

Review case report forms, informed consent forms from investigator sites, reports from clinical research organizations.

Provide information and updates for input into Clinical Trial Management System.

Use of GEL document management (authorship and reviewer privileges); experience with Study Master File; SAS; data edit checks; IMPACT; IVRS-IWRS.

Review and archive study data management files and complete site correspondence.

TEMPLE UNIVERSITY, Philadelphia, PA Aug 2005- Aug 2007

Clinical Research Nurse Coordinator

Work under the supervision of Principal Investigators and Site Director with direct involvement in patient care. Coordinate the conduct of industry and investigator-sponsored clinical research studies (phases I to IV) from pre-study planning through completion of all patient visits and documentation in: Rheumatology, General Internal Medicine with HIV-positive patients, Nuclear Medicine, and Oncology (8/1/2005-11/3/2006); Pulmonary (11/6/2006 -8/3/2007)

Communicate with Principal Investigator (PI), staff, patients, and sponsors to ensure appropriate medical evaluations, patient care, and documentation (e.g., AEs, SAEs).

Conduct all patient visits in compliance with study protocols and good clinical practice.

Master study protocol requirements (e.g., informed consent, patient visits, drug dispensation/accountability).

Complete study documentation (e.g., IRB documentation, protocol submission, case report forms, regulatory documents, source documents).

Manage patient travel stipends and assist with budget development.

Organize patient recruitment; screen patients for eligibility to participate in clinical trials via in-hospital rounds; clinic rounds/referrals from clinic staff; prescreening clinic charts; advertisements.

Participate with PI to obtain informed consent from patients; educate staff and participating patients.

Supervise patient care; obtain vital signs; do phlebotomy, spirometry, and audiometry test; and perform ECGs.

Assess physical, psychosocial, and learning needs of study participants; perform lab procedures and monitor lab results.

Act as patient advocate; recommend patient needs to PI and other health professionals (e.g., case manager).

Participate in Pre-Site Visits, Study Initiation Visits, and Study Close-out Visits.

Attend sponsor Investigator/Study Coordinator research meetings for assigned protocols.

ELSEVIER, INC, Philadelphia, PA 1988-1993; 1996-2005

Senior Developmental Editor, Health Sciences (2001-2005)

Develop competitive, innovative life-of-title strategy for new or revised product designed to improve quality and grow market share. Develop and manage assigned physical therapy and athletic training titles from precontract stage through release to production.

HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA, Philadelphia, PA 1995-1996

Staff Nurse (Primary nurse responsible for 3 to 5 patients in a cardiac intensive care unit)

Certified in Basic Dysrhythmias and Critical Care.

Identify/assess clients' physical, social, and emotional needs; implement comprehensive care plans of heart transplant patients, patients with left ventricular assist devices, and patients after cardiac catheterization.

Monitor patients' vital signs; ensure safety and support; assess for pain and administer medications; initiate referrals for patients and follow up with patients after discharge from hospital.

Licenses, Certifications, and Special Training

Registered Nurse RN506493L Pennsylvania State Board of Nursing (expiration date: 04-30-2021)

Certified Clinical Research Professional (CCRP) (2008 on): SOCRA ID 23643; expiration date: 05-01-2023

Adult and Pediatric First Aid/CPR/AED (02/24/2020; valid for 2 yr)

Basic Dysrhythmia and Critical Care Course (University of Pennsylvania)

SOCRA: Device Research Conference: Regulations & Guidelines for Device Clinical Research, Chicago (5/20-5/21/2009) + Device Basics Pre-Conference Workshop (5/19/2009) (19.7 CE hr)

SOCRA: Advanced Site Management: Finance & Productivity meeting, Philadelphia (10/15-10/16/2009) (12.5 CE hr)

SOCRA: FDA Clinical Trial Requirements: Regulations, Compliance, GCP, Philadelphia (11/16-11/17/2011) (13.3 CE hr)

SOCRA: Grant Writing & Protocol Development Workshop, Las Vegas (09/20/2012) (4 CE hr)

SOCRA 21st Annual Conference, Las Vegas (09/21-09/23/ 2012) (15 CE hr)

SOCRA 22nd Annual Conference, New Orleans (09/27-29/2013) (15 CE hr)

SOCRA 23rd Annual Conference, Orlando (09/19-21/2014) (15 CE hr)

Diabetes Educator Certification Review Intensive CE Series (ICE153) (08/02/2014) (26 CE hr)

Medidata RAVE 5.6 EDC Essentials for Data Managers (10/21/2016)

InForm (IOL-Oracle) 4.6 CRA and CDM Modules (08/19/2016)

SOCRA 24th Annual Conference, Denver, CO (09/18-20/2015 (15 CE hr)

SOCRA 25th Annual Conference, Montreal, Canada (09/30-10/02/2016 (15 CE hr)

SOCRA Oncology Clinical Trials Conference, Nashville, TN (03/14-03/16/2018) (18.5 CE hr)

SOCRA Emergency Clinical Research Symposium, Boston, MA (06/18-06/19/2019) (14 CE hr)

Education

M.A., English Literature and Psychology, University of Aberdeen, Aberdeen, Scotland

Postgraduate Diploma, Library Science (equivalent to MLS in USA), Strathclyde University, Glasgow, Scotland

B.S., Nursing, Thomas Jefferson University, Philadelphia, PA, USA

Technical Skills

Microsoft Word; Microsoft Excel; Microsoft Access; Microsoft Outlook; Microsoft PowerPoint; Microsoft Publisher; Word Perfect; OPAL; OC-RDC; OC-RDC Onsite; SOCS-PRO; ARGUS; SharePoint; INFORM, Medidata Rave; EDMS; GDMS; IMPACT; STAR; METEOR; MARRS; RCAM; ISI Writer; GEL; ANGEL; SAPPHIRE; Business Objects (Sapphire reporting database); SMS (Signal Management System); TAS (Text Analytics for Safety Surveillance); KDP(MIS); PKT; SCEPTRE; IVEA; RightFind monthly literature signaling; ShEDS (Shire’s electronic document system); Please Review

Professional Associations

Sigma Theta Tau International Honor Society of Nursing, Delta Rho Chapter (inducted 04/23/1995)

Society of Clinical Research Associates (SOCRA) (member since June 2006)

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