Funtela Mebane
Durham,USA
Summary
With a proven track record at Parexel International, I excel in leading quality and risk management processes, demonstrating expertise in drug safety and root-cause analysis. My approach, characterized by effective cross-functional coordination and a focus on continuous improvement, has significantly enhanced project outcomes. Methodical professional in quality control, known for high productivity and efficient task completion. Skilled in statistical analysis, process improvement strategies, and regulatory compliance. Excel at problem-solving, critical thinking, and effective communication to ensure quality standards are met and exceeded.
Overview
12
12
years of professional experience
Work History
PV Project Quality and Risk Manager
Parexel International
Durham, NC
06.2024 - Current
- Lead, facilitate and support the risk management process for assigned projects/account using the available tools
- Lead and facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies
- Provide oversight, transparency and tracking of quality issues for assigned projects
- Analyse key risk indicators and investigate risk signals by performing, reporting, and coordinating inspection readiness checks (IRC), including for assigned projects/account using dashboards, reports, metrics and other available tools
- Assist with preparations, conduct and response/action plan development for audits/inspections as assigned
- Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter-experts
- Partner with Operational delivery teams to achieve and maintain inspection-ready state including story board oversight
- Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of dedicated PV PQRM to a client
- Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested
- Mentor PQRLs as assigned
- Manage the relationship with Operations
PV Quality and Risk Principal
Parexel International
Durham, NC
06.2023 - 06.2024
- Analysed key risk indicators and investigate risk signals by performing, reporting and coordinating risk signal evaluations for assigned projects using dashboards, reports, metrics and other available tools
- Facilitated and support the risk management process for assigned projects using the available tools
- Facilitated identification, investigation and remediation of quality issues as assigned using available tools and methodologies
- Provide oversight, transparency and tracking of quality issues for assigned studies
- Assisted with preparations, conduct and response/action plan development for audits/inspections as assigned
- Provided expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts
- Partnered with project teams to achieve and maintain inspection-ready state including story board oversight
- Developed and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality Lead
Safety Project Manager
Primevigilance
Raleigh, USA
08.2022 - 06.2023
- Acted as the primary contact point for project-related matters
- Represented the client's and PrimeVigilance interests with the aim of keeping the agreed project scope
- Managed changes to the project scope, project schedule and project costs, as applicable
- Prepared of client specific core documents (e.g
- Join operational guidelines, Safety management plan, Monthly reports, etc), as applicable
- Advised the client as requested or as appropriate in PV matters such as changes in regulations/guidance
- Managed Quality Management System activities for the client; developed of standard operating procedures and operational guidelines, maintained compliance with the PV system and providing PV training, as required
- Ensured that quality standards applicable to the respective client are met
- Line managed junior colleagues, as applicable, may lead team of colleagues
- Developed PV training presentations and delivering PV training, as required
- Supported quality and efficiency strategies within the company
- Ensured compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA)
Sr. Safety Project Lead
IQVIA
Durham, USA
11.2020 - 08.2022
- Managed customer interface and communication for assigned projects
- Represented Lifecycle Safety on projects and serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams
- Managed customer deliverables for assigned projects and bring continuity to project design and delivery through customer delivery
- Tactical, day-to-day customer-facing leadership at project level
- Responsibilities included project planning (timelines, deliverables), defining project/scope management, quality management and project financial management
- Formulated operational budgetary assumptions and takes decisions to steer the creation of the budget, fulfil required customization of text and data
- Acts autonomously as the Safety Subject Matter Expert (SME) and single point of contact for Governance, Executives and Integrated Partners in construction of proposed solution and defends the strategy and pricing from initiation through to delivery
- Reported to the Director of Projects and (Senior) Project Manager, provide them with a regular update regarding the status of specific projects (overview of all tasks to be delivered to the client, including deadlines and interim milestones) and escalate appropriately, if needed
Sr. Safety Specialist
IQVIA Biotech
Morrisville, United States
05.2017 - 10.2021
- Performed safety case processing tasks including, but not limited to: Intake and triage tasks as performed by Clinical Safety Associate and/or Senior Clinical Safety Associate
- Reviewed incoming safety information for completeness and accuracy
- Tracked and data entry Writing clinical narratives, generating queries Contacting sites for missing and/or unclear information, QC of cases
- Performed Safety Management start-up process included, created Safety Management Plan, developed SAE form and other project specific documents
Safety and Pharmacovigilance Program Delivery Lead
Syneos Health
Morrisville, United States
10.2019 - 11.2020
- Collaborated with Sponsor/Customer and major functional area leads (e.g., Project Management, Clinical Monitoring, SSU, Medical Writing, and Data Management etc.) as the key liaison between the client and Syneos Health Safety & Pharmacovigilance (SPVG)
- Ensured all project deliverables meet the internal and external customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments
- Ensured that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed
- Took corrective measures where necessary to keep project in line with budget and gross profit expectations
- Trained/mentored key SPVG project team members on project/program specific tasks and a working knowledge of the project/program assigned
- Participated in audits/inspections and always ensured inspection readiness
- Participated in quality investigations and implementation of corrective and preventative actions
Case Manager II
Ashfield Pharmacovigilance
Durham, United States
10.2017 - 02.2018
- Extracted, analyse and process adverse event data from a variety of sources including clinical trials, health care professionals, consumers, sales representatives, legal reports, and literature
- Integrated all case-related information including medical conditions, lab results and procedures as well as compile complete narrative summaries and queries
- Ensured the timely submission of reports to worldwide regulatory agencies in accordance with applicable regulations
- Interacted with reporters, sites, and clients as necessary to obtain clarification or follow-up information
- Reviewed, enter and verify follow-up information from spontaneous sources and clinical investigations
- Responded accurately and appropriately to inquiries from clients Analyzed and extract data from legal and literature sources
- Performed searches of the adverse event database for internal compliance and labelling purposes
- Performed standard quality review procedures on cases prepared by other case managers
- Acted as mentor for new staff including training, evaluation, and feedback
- Assisted upper management with preparations for client audits
Operations Specialists
IQVIA
Durham, United States
05.2014 - 05.2017
- Provided oversight and maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow
- Received, triaged, reviewed and processed data from various sources on time, within budget and meet quality standards
- Performed data entry for tracking and safety database, coding relevant medical terminology, writing descriptive narratives, generated queries pertinent to the clinical trial case, performed quality control, assisting with reconciliation, driving case closure, coordinated translations and ensured reports are sent to the customer within assigned deadlines
- Assessed Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement
Medical Communication Specialist
Pharmaceutical Product Development
Morrisville, United States
10.2012 - 05.2014
- Handled inbound and outbound call, emails, fax, and other administrative tasks
- Provided appropriate and accurate technical information while maintaining excellent customer service
- Researched and responded to inquiries
- Created and maintained documentation according to Standard Operating Procedures, protocols, FDA Good Clinical Practices and regulations Responsibilities also included identifying and recording adverse events and product complaints
- Assisted with writing non-serious narratives for post-marketing projects as applicable
- Performed file creation, tracking, retention, and maintenance (paper and electronic); maintains industry reference documentation
- Recorded all adverse event details and source documentation and tracked them in accordance with sponsor specifications
- Acquired basic understanding and maintained knowledge of ongoing projects and disease-related terminology
Education
Bachelor of Science - Public Health
North Carolina Central University
01.2011
Skills
- Retrospective assessment
- Root-cause analysis
- Risk mitigation strategies
- Program design
- Deficiency documentation
- Drug safety expertise
- Medical terminology
- Pharmacovigilance regulations
- Adverse event reporting
- Cross-functional coordination
- Case processing
- Quality assurance techniques
- Post-marketing surveillance
- MedDRA coding
Professionalassociations
American Society for Quality, 2023
Jobtitle
PV Quality and Risk Manager
Locations
- Durham, Durham, NC
- Raleigh, Raleigh, NC
- Morrisville, Morrisville, NC
Languages
English, Fluent
Therapeuticareaexpertise
- Oncology, Non-small cell Lung Cancer, I/II, 2014-2017, Solid tumors Breast, I/II/III, 2018-2023, Chronic Myeloid Leukaemia, 2014-2017, Myelodysplastic Syndrome, 2016-2017, Myeloid Leukaemia, 2017-2022, Ovarian Cancer, 2018-2023
- Diabetes Mellitus, Type 2, 2014-2018
- Infectious Disease, Clostridium Difficile, 2014-2016, COVID-19, Phase II/III and Emergency Authorization Use, 2020-2022
- Gastroenterology, Ulcerative colitis, Phase I/II, 2022-2023
- Marketed Products, Birth Control (Intrauterine device), 2022-2023, Respiratory - Allergy, 2012-2014, Diabetes Mellitus, Type 2, 2012-2014, Ulcerative colitis, 2020-2022
Summary Of Experience
Funtela Mebane has over a decade experience in the Contract Research Organization (CRO) Industry. Funtela Mebane's CRO experience commenced in 2012. Over the past 10 years Funtela has gained diverse exposure across the entire continuum of the Drug Lifecycle Management. Funtela has served as safety management primary and back-up lead on small to moderate sized global studies that were simple to moderate in complexity. Over the course of her career, she has cultivated a positive, collaborative team environment and led by example. She has managed the start-up, maintenance and close-out activities for clinical trial and post-marketing programs that included leading local and global PV teams that deliver on time and with quality globally for large and small clients.
Timeline
PV Project Quality and Risk Manager
Parexel International
06.2024 - Current
PV Quality and Risk Principal
Parexel International
06.2023 - 06.2024
Safety Project Manager
Primevigilance
08.2022 - 06.2023
Sr. Safety Project Lead
IQVIA
11.2020 - 08.2022
Safety and Pharmacovigilance Program Delivery Lead
Syneos Health
10.2019 - 11.2020
Case Manager II
Ashfield Pharmacovigilance
10.2017 - 02.2018
Sr. Safety Specialist
IQVIA Biotech
05.2017 - 10.2021
Operations Specialists
IQVIA
05.2014 - 05.2017
Medical Communication Specialist
Pharmaceutical Product Development
10.2012 - 05.2014
Bachelor of Science - Public Health
North Carolina Central University
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