Janet Mauger

*** ******* **** 484-***-****

Schwenksville, PA 19473 ad38a5@r.postjobfree.com

SUMMARY

Licensed, professional, registered nurse with a Bachelor’s degree in Nursing and over fifteen years of extensive pharmaceutical industry experience, in the areas of drug safety & clinical research. Experience in varied therapeutic areas, multiple databases including Argus and ARISg, and from all sources, including, but not limited to, post-marketing, clinical trial reports, literature and litigation. Also, pharmaceutical call center experience and certified clinical research associate with over six years of direct clinical monitoring experience, including paper, as well as, electronic case report forms. Strengths include efficiency, organizational ability, extreme attention to detail, and ability to transition and master new concepts quickly and completely.

PROFESSIONAL EXPERIENCE

RHO, INC., Durham, NC Mar-2022-Sep-2023 Medical Monitoring Associate

·Work in close cooperation with Medical Directors to set up and coordinate the medical data review process, including assisting with medical data review and managing medical queries.

·Review and track medical data from clinical studies including but not limited to listings of adverse events, medical history, concomitant medications, subject withdrawals and protocol deviations for accuracy and compliance with study protocols.

·Using medical knowledge to issue and respond to medical queries, while consulting with Medical Director, as appropriate.

·Triage medical monitoring phone calls and emails.

·Creation and maintenance of medical data review summary report for periodic discussions with Sponsor in monthly medical data review meetings.

·Creation of ad hoc reports as needed e.g. potential safety signals, endpoint adjudication, specific EDC reports, etc.

PROPHARMA GROUP, Fort Washington, PA Nov-2020-Dec-2021 Senior Clinical Pharmacovigilance Specialist

·Manages individual case safety reports (serious adverse events, adverse events of interest and reports of pregnancy) through intake, documentation and processing.

·Responsible for coding safety data using Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) drug dictionaries.

·Performs initial case-level assessment of expectedness; confirms seriousness; composes accurate and thorough medical narratives and generates site queries for missing or unclear information.

·Ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, SMPs, SOPs and applicable safety regulations.

VIGILARE INTERNATIONAL, Plymouth Meeting, PA Aug-2018-Oct-2020 Safety Scientist

·Receives safety related information via telephone calls, faxes, e-mails, web portals, etc, from health care professionals, study coordinators, patients, caregivers and other parties reporting potential adverse events

·Provides Notification to sponsors, clinical contract research organizations (CRO’s), Vigilare Team and others within 24 hours of receipt

·Completely and accurately documents reports involving adverse event information

·Codes safety data using MedDRA and WHO drug dictionaries and other coding schemes

·Establishes and maintains auditable safety files in accordance with Good Pharmacovigilance Practices and International Conference on Harmonisation (ICH) standards

ENDO PHARMACEUTICALS, Malvern, PA Jul-2017 – Aug-2018 Senior Drug Safety Scientist

·Receive, process, and distribute spontaneous adverse event reports and clinical study SAE reports – review for medical/regulatory content and obtain follow-up as needed

·Process all types of adverse event reports utilizing the safety database

·Collaborate with team physicians to ensure reports are processed appropriately

·Assess expectedness of adverse events based on product labels, investigator brochures, and core safety information

·Review medical records, identify/obtain appropriate follow-up; ensure adequate documentation for safety assessment

UNITED BIOSOURCE, Blue Bell, PA Sep-2015 – Jul-2017 Safety Scientist

·Responsible for processing and evaluation of individual case safety reports (ICSR) according to customer’s standard operating procedures (SOP’s) including coding, data entry, narrative composition, seriousness determination, causality and expectedness assessment and generation of queries and reports

TELERX, Horsham, PA Jul-2014 – Sep-2015 Surveillance Associate

·Responsible for participating in adverse event case management, to include assisting Team Leads and Pharmacovigilance Specialists in client related Adverse Event Management activities, processing cases under the single case ownership models as to remain current with the activity, and providing support to other Safety Monitors in terms of the clinical management of the case and its prioritization

·Supports clients on assigned team or teams, depending upon volume and case complexity, and resolves issues and works with the Associate Medical Safety Officer and Team Leads to consistently assess case quality and establish plans and actions for improvements

MERCK & COMPANY, Lansdale, PA Jul-2012 – Jul-2014 Adverse Experience Reporting Coordinator III (contract position)

·Determines, on the basis of SOP’s and FDA regulations, the prompt or periodic classification of each adverse experience contained in the reports received for Merck marketed and investigational products

·Responsible for data entry, coding, processing and review, according to the SOP’s of all adverse experience information received for domestic and non-domestic sources which involve Merck

PFIZER, Collegeville, PA Jul-2010 – May-2012 Safety Surveillance Associate

·Responsible for the triage, data entry, review, coding, processing, and follow-up of clinical trial and post-marketing adverse events reports into Argus database

·Responsible for extensive narrative composition summarizing patient adverse events according to SOP’s within appropriate regulatory reporting timeframes

·Responsible for the case classification of all incoming reports for validity, seriousness, and expectedness

·Determine and perform appropriate case follow-up, generating and requesting follow-up letters

·Develop and maintain expertise and knowledge regarding data entry conventions, assigned products with therapeutic area and applicable corporate and global regulations, guidelines, SOP’s, and writing practices

PHARMANET, Blue Bell, PA Feb-2010 – May-2010 Senior Drug Safety Associate (contract position)

·Responsible for the data entry, review, coding, processing, and follow-up of clinical trial adverse event reports to worldwide regulatory agencies

·Responsible for extensive narrative composition summarizing patient adverse events according to SOP’s within appropriate regulatory reporting timeframes

·Responsible for query generation in regards to clinical trial SAE reports

ICON CLINICAL RESEARCH, North Wales, PA Sep-2009 – Jan-2010 Senior Drug Safety Associate (contract position)

·Responsible for call intake, review, coding, classification, processing and follow-up of spontaneous post marketing adverse event reports to worldwide regulatory agencies

·Responsible for narrative composition summarizing patient adverse events according to SOP’s within appropriate regulatory reporting timeframes

OMNICARE, King of Prussia, PA Apr-2009 – Sep-2009 Drug Safety Officer (contract position)

·Responsible for the data entry, review, coding, processing and follow-up of clinical trial and post-marketing adverse event reports to worldwide regulatory agencies

·Responsible for extensive narrative composition summarizing patient adverse events according to SOP’s within appropriate regulatory reporting timeframes

·Responsible for query generation and maintenance of various tracking logs in regards to clinical trial SAE reports

·Responsible for Safety representation at internal and external clinical trial working group meetings

CEPHALON, Frazer, PA Mar-2008 – Feb-2009 Drug Safety Associate (contract position)

·Ensure timely and accurate data entry of adverse drug experience reports (ADRs) received from all sources, including, but not limited to, spontaneous post-marketing and clinical trial reports, literature/scientific publications, line listings and pregnancy reports

·Responsible for the determination of listedness and expectedness of individual ICSR’s according to reference documents and for the appropriate selection of PT/LLT MedDRA terms

·Review the overall ICSR for accuracy, completeness and consistency, including review and generation of medically correct case narratives

·Request, obtain and generate appropriate ICSR follow-up and perform SAE reconciliation

·Assist in the review of legacy data for completeness and consistency as entered into Clintrace

MERCK & COMPANY, Blue Bell, PA Mar-2005 – Feb-2008 Drug Safety Associate (contract position)

·Responsible for the review, coding, classification and processing of post-marketing litigation adverse event reports, including determination of reportability to worldwide regulatory agencies

·Responsible for narrative composition summarizing patient adverse events according to SOP’s within appropriate regulatory reporting timeframes

ADOLOR, Exton, PA Oct-2002 – Mar-2005 Senior Clinical Research Scientist

·Responsible for in-house monitoring of clinical study sites and activities

·Assisted in the day to day management of investigational sites

·Assisted in the site close-out and data management process including the collection and cleaning of data and the identification and resolution of data queries

·Responsible for SAE & investigator file reconciliation of four pivotal Phase III studies

·Assisted in the quality review of the company’s NDA prior to submission to the FDA

·Assisted in the writing of SAE narratives for inclusion in the NDA submission

ASTRAZENECA, Wilmington, DE 1995 – Oct-2002 Senior Clinical Research Scientist

Conducted pre-study, site initiation, interim and site close-out visits for Phase II and III clinical trials involving Parkinson’s disease, epilepsy and asthma

Participated in initial electronic data capture studies

Ensured GCP and protocol adherence, maintenance of site regulatory documents and proper clinical supply management at investigational sites

Assisted in the day-to-day management of investigational sites and regional monitors

Performed SAE reconciliation between the Clinical and Safety databases

Assisted in the data management process including the collection and cleaning of data and the

identification and resolution of data queries

Assisted with the management of study budgets and investigator payments

Assisted in the composition of the clinical section of the annual IND reports

Product Safety Specialist 1996 – 1997

·Responsible for the coding, classification and processing of adverse event reports

Information Specialist 1995 – 1996

·Responsible for responding to telephone inquiries from consumers, physician, pharmacists and other healthcare professionals regarding AstraZeneca, and/or, it’s products, within FDA and AstraZeneca guidelines

ADDITIONAL RELEVANT EXPERIENCE

Practiced as a professional registered nurse, providing direct patient care in major university-based hospitals, for over seven years. Area of expertise included orthopedics/trauma

EDUCATION

BSN, Pennsylvania State University, University Park, PA

Graduated Dean’s list three semesters

Nominated to Nursing National Honor Society

PROFESSIONAL LICENSURE & CERTIFICATIONS

Professional Registered Nurse in the Commonwealth of Pennsylvania: Certificate No. RN 276357L Certified Clinical Research Associate through ACRP: Certificate No A99480

TECHNICAL SKILLS

Microsoft Office: Word, Excel, Outlook, Internet applications

Safety Databases: ARISg, Argus, Clintrace

Coding Languages: MedDRA, WHO-Drug

Document Management: SharePoint

Software Applications: AdobePro

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