Wilma L. Porter
Scotch Plains
Summary
General supervisor bioanalytical experience, including data review for multiple projects to assure high quality of reported data. Accomplished Senior Scientist with years of progressive excellence working with leading global pharmaceutical industries supporting the development and bringing to market a range of innovative pharmaceuticals across a spectrum of pathologies including Cardiovascular, CNS, Infectious Diseases and Oncology. Meticulous technician with a range of advanced laboratory skills practiced in varied methodologies, procedures and protocols supporting advanced experiments, research, trials and related documentation. Demonstrated abilities in the collection, management and related analysis of a broad range of experiments, research and pre-clinical and clinical data. Substantial knowledge of methodologies focused on protocol design and execution, experienced in coding using MedDRA, WHO Drug dictionary, and reporting using Individual Case Safety Report guidelines. Expertise in the analysis of diverse animal models relating to pharmacokinetic and pharmacodynamic relationships for preclinical drug discovery and pharmacovigilance signals detection and reporting of post marketing products. Demonstrated abilities in compliance assurances with all FDA, OSHA, ICH, GCP, EMA, GLP, and Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) regulations, policies and practices.
Overview
34
34
years of professional experience
Work History
Development Database Coordinator
COUNT BASIE THEATER
10.2023 - Current
- Company Overview: The Count Basie Center for the Arts is New Jersey’s premier center for the cultural arts and its commitment to being a diverse, equitable and inclusive (DEI) performing arts organization is at the core of our mission to Inspire, Educate and Entertain
- Worked as an integral member of the Count Basie Center Development team Reporting to the Senior Director of Development
- Responsible for managing the Raiser’s Edge/NXT database that serves as the foundation for all development programs including membership, events, sponsorships, grants, endowment, specific campaigns, and major giving
- Also, serve as the backbone of the operation and provide administrative support to the team
- The Count Basie Center for the Arts is New Jersey’s premier center for the cultural arts and its commitment to being a diverse, equitable and inclusive (DEI) performing arts organization is at the core of our mission to Inspire, Educate and Entertain
Quality Support Specialist
MONMOUTH CARES
03.2022 - 06.2023
- Company Overview: A non-profit Care Management Organization (CMO) in Monmouth County, NJ serving youth and families
- Monmouth Cares is part of the NJ Children’s System of Care that helps youth and families with emotional, behavioral, substance use, and intellectual/developmental disabilities needs
- Perform daily and monthly Power BI report refreshes for Care Mangers for tracking of and data and information
- Perform monthly SharePoint Payment Error Rate Measurement (PERM) report to track and assess quality and compliance to evaluate minimum care management to families
- Perform Ad-hoc data requests, i.e
- Billing Excel – VLOOKUP tracing, Pivot tables summaries (FSO and WFI’s), etc
- A non-profit Care Management Organization (CMO) in Monmouth County, NJ serving youth and families
- Monmouth Cares is part of the NJ Children’s System of Care that helps youth and families with emotional, behavioral, substance use, and intellectual/developmental disabilities needs
Contract PV Associate
UROGEN PHARMA/ATLAS SEARCH LLC
01.2021 - 10.2021
- Company Overview: Contract assignment for UroGen Pharma a biopharmaceutical company that builds novel solutions to revolutionize the way specialty cancers and urologic diseases are treated
- Work with the PV vendor to ensure that individual case safety reports (ICSRs) for adverse events were collected, reviewed, and processed in a timely manner, and in accordance with the appropriate company SOPs, study protocols, and regulatory guidelines
- Manage Post-Marketing and Clinical Trial case reports for weekly and quarterly monitoring and reporting
- Coordinate agenda for periodic Safety Review Team (SRT) meetings and lead the preparation of all meeting materials and minutes
- Contract assignment for UroGen Pharma a biopharmaceutical company that builds novel solutions to revolutionize the way specialty cancers and urologic diseases are treated
Contract PV Scientist
BRISTOL MYERS SQUIBB/ALPHA CONSULTANT CORP
08.2019 - 08.2020
- Company Overview: Contract assignment for Bristol Myers Squibb (BMS) a leading global pharmaceutical and biologics manufacturer of prescription pharmaceuticals and biologics in several therapeutic spaces
- Support with operational pharmacovigilance activities for BMS marketed products
- Performed evaluations of serious adverse event reports from spontaneous reports, clinical trials non-clinical reports and scientific literature with oversight
- Provided technical support to Medical Review Safety Physicians (MRSPs) including review and interpretation of source documents; performed periodic summary of pertinent safety-related literature; analysis of pre-determined core signal data; benefit-risk assessment summaries, evaluations, and conclusions with oversight
- Utilized BMS safety and clinical databases to prepare contextual summaries for safety reports
- Reviewed and commented on documents and line listings from WWPS, other BMS departments, and other drug development/marketing partners and contractors
- Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s) in a specified therapeutic area
- Appropriately elevate signal detection findings impacting risk benefit to the MST Chair
- Authored PV contributions to specified sections of aggregate reports writing (DSUR and PSUR) as required with oversight
- Participated in the continuous benefit risk assessment of BMS mature products with the set-up of processes such as periodic aggregate data review, signal management etc
- Authored safety data query responses to health authorities including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries with oversight
- Contract assignment for Bristol Myers Squibb (BMS) a leading global pharmaceutical and biologics manufacturer of prescription pharmaceuticals and biologics in several therapeutic spaces
Contract Data Analyst II
SANOFI / CYBERTHINK INC.
01.2019 - 08.2019
- Company Overview: Contracted Data Analyst for Sanofi S.A., a leading French multinational pharmaceutical company for CyberThink staffing
- Managed, compiled, and ensured compliance with Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Phoenix TK and PK datasets for upload to SEND system to ensure compliance with FDA regulations and documentation practices
- Contracted Data Analyst for Sanofi S.A., a leading French multinational pharmaceutical company for CyberThink staffing
Contract Lead Scientist & Study Coordinator
COVANCE / REAL STAFFING INC.
08.2017 - 07.2018
- Company Overview: Contracted Lead Scientist & Study Coordinator for Covance Inc., a leading contract research organization (CRO) providing drug development and animal testing
- As Study Coordinator, ensured the timely execution, finalization, and compliance with all Covance, GLP and FDA policies, practices, and regulations for the close-out of pre-clinical and clinical trials
- As Technical Writer, completed and complied with all SOPs and reporting guidelines for the timely preparation and completion of Final Study Summary, Supplemental Validation Study Close-out Report, Analytical Validation Plan (AP) amendments, Analytical Methods (AM) updates, and SOP’s deviations
- As Lead Scientist, ensured study accuracy and data integrity of LC-MS quantitation results
- Managed study documentation including Watson Laboratory Information Management System (LIMS) study design, samples acquisition list and Incurred Sample Repeats (ISR’s) analysis list, and the proper archival of final study documentation
- Contracted Lead Scientist & Study Coordinator for Covance Inc., a leading contract research organization (CRO) providing drug development and animal testing
Contract SPF Coordinator
L’ORÉAL CORPORATION
03.2017 - 08.2017
- Company Overview: Contract SPF Coordinator for L'Oréal S.A., the world's largest cosmetics company and personal care company
- Primary liaison for outsourcing sunscreen testing (SPF and UVA) for Skin, Makeup, and Hair products
- Managed contractor performance and ensured compliance with all FDA and EU testing regulations
- Managed all finance activities including budget adherence, coordinated, and reviewed submitted Request for proposals (RFP), managed vendor selection, and ensured the timely coordination of Purchase Orders (PO) and invoices (CGR)
- Contract SPF Coordinator for L'Oréal S.A., the world's largest cosmetics company and personal care company
Scientist I & Lab Coordinator
NOVARTIS PHARMACEUTICALS CORPORATION
09.2015 - 07.2016
- Company Overview: Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
- Coordinated and monitored preclinical bioanalytical study assignments at CRO’s ensuring compliance with scientific integrity, study protocols, quality, timelines, and budget constraints
- Managed and ordered a range of supply requests for preclinical, clinical, and biologic studies for the Early Bioanalytic Technology (EBT) laboratory
- Directed study outsourcing and managed preclinical and clinical drug substance supply
- Supported the robust collection of data and related reporting as required
- Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
Investigator II
NOVARTIS PHARMACEUTICALS CORPORATION
03.2008 - 09.2015
- Company Overview: Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
- Planned, assigned, and managed preclinical bioanalytical study assignments for scientific integrity, quality, target, budget constraints and compliance assurances with all protocols and regulations, policies, and practices
- Managed and coordinated preclinical outsourcing program ensuring study integrity
- Authored pharmacokinetic (PK) evaluation and interpretation summary and contributed and performed quality review of Toxicokinetic LC-MS/MS small molecule studies and reports
- Delivered agile responses to dynamic operational and study needs
- Effectively operated a range of tools consistent with a semi-automated GLP laboratory for sample preparation including Tomtec multimodal l handling system, and a range of software tools including sample quantification using Analyst software, LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS) as well as WinNonlin Statistical Software
- Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
Senior Scientist
NOVARTIS PHARMACEUTICALS CORPORATION
03.2002 - 03.2008
- Company Overview: Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
- Lead analytical scientist with demonstrated success in the development, optimization, and validation of Liquid chromatography and mass spectrometry assays (LC/MS) in biological fluids that included protein precipitation, liquid-liquid, SPE, Dried and Blood Spot extractions in an Analyst Software environment in clinical trials
- Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
Lab Technician
NOVARTIS PHARMACEUTICALS CORPORATION
01.1991 - 03.2002
- Company Overview: Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
- Twenty-five years of progressive excellence and promotions with a leading multinational pharmaceutical company
Education
Bachelor of Science - Chemistry
MONTCLAIR STATE UNIVERSITY
Upper Montclair, NJCertificate - Clinical Research and Drug Safety Analytics
Sollers College
Edison, NJ01.2019
Cross-Sectional Rotation -
Novartis Pharmaceuticals
East Hanover, NJ01.2015
Skills
- Research Scientist
- Pre-Clinical & Clinical Trials
- Data Collection & Management
- Pharmacovigilance (PV)
- Protocol, SOP & Regulatory Compliance
- Data Analysis & Bio-Analytics
- Protocol Design
- Outsourcing Coordination & Management
- Biological Sampling
- Study Communications
- Regular Writing
- Special Writing
- Ad-hoc Writing
- MedDRA Coding
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Watson Laboratory Information Management System (LIMS)
- Oracle Argus Safety 80
- Analyst software
- WinNonlin
- MedDRA
- WHO Drug dictionary
- Individual Case Safety Report (ICSR)
Websites
Productivity And Research Tools
- Microsoft Word
- Excel
- PowerPoint
- Watson Laboratory Information Management System (LIMS)
- Oracle Argus Safety 8.0
- Analyst software
- WinNonlin
- MedDRA
- WHO Drug dictionary
- Individual Case Safety Report (ICSR)
Research Posters And Publications
available upon request
Professional Development
- 2019, Clinical Research and Drug Safety Analytics, Sollers College, Edison, NJ
- 2015, Cross-Sectional Rotation, Novartis Pharmaceuticals, East Hanover, NJ
Languages
English
Full Professional
Timeline
Development Database Coordinator
COUNT BASIE THEATER
10.2023 - Current
Quality Support Specialist
MONMOUTH CARES
03.2022 - 06.2023
Contract PV Associate
UROGEN PHARMA/ATLAS SEARCH LLC
01.2021 - 10.2021
Contract PV Scientist
BRISTOL MYERS SQUIBB/ALPHA CONSULTANT CORP
08.2019 - 08.2020
Contract Data Analyst II
SANOFI / CYBERTHINK INC.
01.2019 - 08.2019
Contract Lead Scientist & Study Coordinator
COVANCE / REAL STAFFING INC.
08.2017 - 07.2018
Contract SPF Coordinator
L’ORÉAL CORPORATION
03.2017 - 08.2017
Scientist I & Lab Coordinator
NOVARTIS PHARMACEUTICALS CORPORATION
09.2015 - 07.2016
Investigator II
NOVARTIS PHARMACEUTICALS CORPORATION
03.2008 - 09.2015
Senior Scientist
NOVARTIS PHARMACEUTICALS CORPORATION
03.2002 - 03.2008
Lab Technician
NOVARTIS PHARMACEUTICALS CORPORATION
01.1991 - 03.2002
Bachelor of Science - Chemistry
MONTCLAIR STATE UNIVERSITY
Certificate - Clinical Research and Drug Safety Analytics
Sollers College
Cross-Sectional Rotation -
Novartis Pharmaceuticals
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