MIRABEL LEM WERIWOH

*** **** *** ***** 615-***-****

Nashville, TN, 37208 adh0kb@r.postjobfree.com

PHARMACOVIGILANCE

Offering strong skills in Pharmacovigilance and risk management activities. Strong experience regarding case processing, management and reporting in the Argus Database. Great coding abilities (using MedDRA and WHO dictionary) coupled with strong expertise in signal detection.

COMPETENCIES/ CORE STRENGTHS

•Self-manager; highly motivated

•Able to use PubMed for Literature Reviews

•Quick learner especially with systems and databases; very hardworking

•Possess data management and data analytics skills [with experience in SPSS, STATA, EPI INFO, Geographic Information System (GIS), SAS, QlikView’s]; Knowledge of FDA Drug and medical devices regulations.

•Organized, detailed oriented, customer- and quality-focuse, customer service representative skills

•Possess ability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text, good knowledge of medical terminology

•Great communication ability/ multilingual; active listener; multitasker; ability to work independently and within strict timelines

•Proven flexibility and adaptability when working in a team, using good judgement in making decisions

• Knowledgeable in MS office package (Word, Excel, PowerPoint, Outlook, SharePoint).

PROFESSIONAL EXPERIENCE

Quality Assurance Analyst, QAA, 3 and 4 2018 – 2020

Philips North America, Nashville, TN

•Promoted from QAA 3 to QAA 4 Position

•Supported Post Surveillance / [Corrective and Preventive Actions (CAPA)] activities by tracking key performance indicators relevant to the Productivity of the business unit.

•Assisted with Daily Management Boards, data management of medical device complaints using Legacy and QCM TrackWise database, SAP, ServiceMax Console systems.

•Assisted in problem solving using PRIDE, Kaizen etc; acquired certification related to the coding of MRI and Ultrasound cases.

•Performed leadership roles (Volunteered Employee Engagement Champion: brought groups of individuals to participate in the company’s surveys); trained/ mentored newly hired analyst on the team.

•Translated French cases into English.

Pharmacovigilance Scientist (Remote Position) 2017-2018

Aven Pharma, New York, NY

•Participated in signal analysis, Data mining & assessment activities in EMPIRICA Signal & Topics

•Assisted in preparation and review of aggregate reports like PSURs and Annual Safety Report

•Used the safety database system, Argus, for individual case safety reports.

•Triaged the Adverse Events (AEs) using seriousness criteria for clinical study and spontaneous AE reports; validated & prioritized AEs.

•Reviewed the extracted info from the source documents by the associates for completeness.

•Promptly and accurately interpreted and entered serious and non-serious adverse events.

•Provided accurate coding of incoming serious and non-serious adverse events using MedDRA terminology and WHO-Drug Dictionary.

•Created comprehensive narratives procured from various source documents.

•Evaluated and summarized the information and initiate investigations.

Independent Consultant / Instructor 2016 – 2018

Division of Clinical Skills & Competencies - Meharry Medical College, MMC, Nashville, TN

•Assisted with the training and assessment of medical students regarding their clinical skills (from 1st to 4th year medical students)

Volunteer Research Assistant 2013- 2016

Tennessee State University (TSU – MMC)

•Assisted with the development of the second beta version of the TSU -Environmental Justice (EJ) Community Information Web Site project ( https://sites.google.com/site/ejinfotnstate/home)

•Assisted with the delivery of workshop(s) on how to navigate the website at local & regional environmental justice meeting(s)

•Assisted with the development of online survey instrument designed to assess the efficacy of the website for EJ stakeholders and health professionals (via GIS workshops at Meharry Medical College from 2010-2013); evaluated and analyzed EJ stakeholders’ responses to the survey; disseminated the results of the analysis via research publications and professional presentations

Research Assistant 2011 - 2013

Internal Medicine Department, MMC, Nashville, TN

•Coordinated all the activities involved in the realization of the community- based participatory research (CBPR) on Cancer Prevention Clinical Trials, CPCTs, funded by the National Cancer Institute

•Assisted with Literature search with PubMed / EndNote, data management, data analysis and manuscript writing; attended a training program in South Carolina regarding another CBPR on Obesity Reduction Intervention (ORI) project. Coordinated the activities related to the implementation of the ORI project in Nashville

Research Assistant 2010 – 2011

Surgery Department, MMC, Nashville, TN

•project; Coordinated the breast-feeding pilot study; assisted with data management

Research Assistant 2010 -2011

Neuroscience Department, MCC, Nashville, TN

•Assisted with literature search using PubMed; analyzed and interpreted environmental pollutant data using GIS; Attended EJ conference

Research Assistant 2009 – 2010

Surgery Department, MCC, Nashville, TN

Data management for the project ‘Meat, Fish, Eggs and Dairy Products in Prostate Cancer Risk among African-Americans.’

Medical Laboratory Technician 2008 – 2009

Biosante International, Yaounde, Cameroon

•Worked as a Laboratory technician in the department of serology and Microbiology

•Worked as a bilingual Medical Representative (promoted partnership between Hospitals and the lab)

EDUCATION & ACADEMIC CREDENTIALS

•Masters of Science in Public Health (Epidemiology minor) 2011

Meharry Medical College, Nashville, TN

•Internship 2011

Department Of Environment, Metro Public Health Department, Nashville, TN

• Bachelor in Biochemistry (Molecular Biology minor) 2006

University of Yaounde I, Yaounde, Cameroon

PROFESSIONAL CERTIFICATIONS

• Oracle Argus Essentials Professional Certification 2020

• Oracle Empirica Signal Professional Certification 2020

•Bill George Certificate on Self-awareness, Authenticity, and Leadership 2020

•Project Management and Customer service foundation certifications 2020

• Medical Laboratory Technology Certification 2008

PUBLICATIONS / POSTER PRESENTATIONS

•Author of Master of Science in Public Health (MSPH) thesis entitled: Perinatal Factors & Breast Cancer among Hispanics (2011);

•Co-author of three Publications (Cancer Prevention Trials; Breast Cancer; Environmental exposure)

•Four poster presentations (On Cancer prevention trials, Obesity, Breast Cancer & Prostate cancer)

Contact this candidate