Data Entry Support Specialist

ADRIENNE HUGHES BURKS

Edison, NJ ***** Phone: 732-***-**** ********@*****.***

PROFILE

Operations leader with seven years of working within the pharmaceutical industry. Outstanding customer service, quality control analyst and data entry specialist. A proven track record of conflict resolution, organizing schedules and databases, and building relationships with a focus on the needs of patients, will be a valuable addition to any hospice setting seeking a client-focused problem solver who can carry out tasks with minimal supervision.

CORE COMPETENCIES

TOOLS: Microsoft 365 Suite (Word, Powerpoint, Excel) Oracle Databases (Siebel, Comet) ARISg 6.5

SKILLS: Administrative Medical Office Procedures Patient Communications and Registration SOAP

In-Depth Medical History Documenter Medical Terminology EHR/EMR Coding Insurances Claim

Processing Cash Handling Credit Card Processing Scheduling Appointments Payment

Collections Invoicing ICD-10-CM Compliant HIPAA Requirements and Guidelines Experienced in Maintaining Sensitive and Confidential Information Green Belt Six Sigma Excellent

Interpersonal Skills Multitasker Oral and Written Communication

PROFESSIONAL EXPERIENCE

Genpact Pharmalink - Associate, Global Regulatory Affairs Sanofi PQC

ANALYST/ASSISTANT MANAGER 03/2021 - 06/2023

● Lead Product Quality Complaints (PQC) operations and manage all aspects of complaint handling from intake to closure to ensure execution and compliance with internal SOPs and regulatory requirements for Sanofi Pharma, Pasteur, CHC and Genzyme products.

● Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.

● Optimized the efficiency of allocated resources to deliver results through metrics and KPIs.

● Provided monthly site reports to investigation sites and daily case load planning. Reviewed and ensured inquiries handled by CS, PV and MIS were compliant with Combination Product guidelines.

● Discussed daily caseload planning, provide end of day report, monthly metrics, communications with interpretation of data analysis and potential problems to Management

● Provided GMP guidance for quality and compliance activities for Sanofi medical devices and drug device combination products, to ensure compliance with established regulations

● Lead a team of 8 Complaints Analysts, provide guidance and response to Analyst’s queries, QC Adverse Event, Potential Expedite, priority technical complaint inquiries and AE closeout reconciliation.

● Suggested continuous improvements to departmental process flow on drug products, biologics and combination products/medical devices.

● Trained new team members in various PQC-related functions.

● Managed client partner relationships to ensure the achievement of key business objectives, compliance with cGMP regulations and good business practices.

● Oversaw the conduct of monitoring/co-monitoring activities for site initiation, interim site monitoring, and closeout, in compliance with all governing laws, regulations, guidelines, protocol, and internal SOPs/policies.

● Maintenance of study regulator documents, including screening and enrollment logs, drug accountability logs and maintained the completion of case report forms (CRFs).

● Identified site findings with the ability to re-train, place corrective action, and follow-up as required.

● Assisted Project Management with risk assessment and mitigation strategies.

ANALYST/ASSOCIATE 12/2020 - 03/2021

● Interacted with complainants and obtained essential information required to document technical complaints.

● Identified and confirmed inquiries as product technical complaints, evaluated for risk to public safety.

● Notified interested departments (including manufacturing site QA, commercial, regulatory, supply chain) upon receipt of critical complaints.

● Monitored and tracked sample receipts from critical complaints.

● Ensured complaints are reviewed and processed within a timely fashion.

● Prioritized complaints for data entry and processing into the department PTC database.

● Utilized the customer service database to oversee complaint identification and processing.

● Interacted with both internal and external manufacturing sites regarding technical complaints and their associated investigations.

● Performed file review and administrative closure for individual complaints.

● Produced and sent monthly reports to responsible manufacturing sites listing monthly complaint activity.

● Interact with Customer Service, Medical Information, Pharmacovigilance and other departments/associates regarding the identification and evaluation of technical complaints.

● Identified and reported adverse events within one business day to Pharmacovigilance.

● Provided complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.

● Participated in ad-hoc teams regarding product-specific complaint issues.

● Supported Product Quality Complaint Managers/Director during regulatory, third party, and internal audits.

● Provided feedback to customers regarding complaint investigations via phone or email.

ANALYST/TECHNICIAN 12/2020 - 03/2021

● Prioritized complaints for data entry and processing.

● Trained in Federal cGMP’s and FDA with emphasis on complaint handling regarding pharmaceutical combination products, biologics, and medical devices.

● Knowledge of timelines regarding Product Technical Complaints within SOP guidelines.

● Understands departmental process flow on drug and device complaints.

● Proficient with use of all the department’s databases (i.e. ACES-Siebel, Global PTC Database, MS Office).

● Identified and prepared appropriate mailers for use in retrieving the complaint samples.

● Produced daily reports for follow-up activity.

● Identified and managed lot discrepancies correctly with returned complaint samples.

● Understands export requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.

● Identified and prepared complaint samples for shipping to manufacturing sites.

● Provided support to US Product Quality Complaint Managers/Director during audits by FDA, other regulatory agencies, third parties and internal groups.

● Notified departments (including QA, commercial, regulatory, supply chain) upon receipt of complaints.

● Provided complaints support to other company departments including but not limited to customer service, Pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management.

EDUCATION

Avtech Institute of Technology - South Plainfield, NJ

Certified Medical Administrative Assistant (CMAA) Certification – Certification expected: 2025

Sanofi Pharmaceutical/Genpact Pharmalink - Bridgewater, NJ

Green Belt Six Sigma - 2021

Clinical Research Academy of America - Edison, NJ

Advanced Clinical Research Program - 2013

The Cittone Institute - Edison, NJ

Certified Medical Administrative Assistant (CMAA) Certification - 2003

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