KIMBERLY ALBEA
Wake Forest
Summary
Accomplished and detail-oriented Senior Drug Safety Specialist with 26+ years of extensive expertise in pharmacovigilance and drug safety within the pharmaceutical sector. Develops and executes robust safety governance frameworks to ensure regulatory excellence and fortify global data integrity standards. Orchestrates cross-functional collaborations to refine adverse event reporting systems, empower high-performing teams, and deliver operational superiority. Employs advanced acumen in regulatory submissions, risk management, and signal detection strategies to spearhead innovative initiatives, driving unparalleled standards in drug safety leadership.
Overview
28
28
years of professional experience
Work History
Manager of Drug Safety
Leadiant Biosciences, Inc.
Rockville
07.2012 - Current
- Performed pharmacovigilance activities for a rare disease pharmaceutical company, including adverse event evaluation, signal detection, and regulatory reporting to the FDA and Health Canada.
- Developed and maintained detailed SOPs for full-cycle drug safety processes, ensuring compliance with GCP, ICH, and global regulations.
- Led cross-department collaboration, conducted employee training, and managed safety databases (ARGUS, MedDRA, WHO Dictionary), ensuring accuracy, consistency, and readiness for regulatory audits.
- Secured exemplary FDA audit outcomes by meticulously preparing and submitting accurate documentation, ensuring compliance and audit readiness.
- Recognized individually for contributions, with no significant findings reported during audits.
- Earned Pharmacy Technician Certification to enhance knowledge of drug classifications, demonstrating a proactive commitment to personal development and advancing expertise within the pharmaceutical industry.
- Promoted Drug Safety Specialist to Senior Drug Safety Specialist in recognition of exceptional performance and leadership, with direct acknowledgment from the VP of Pharmacovigilance for outstanding contributions and professional development.
- Developed and maintained a centralized procedural document for adverse event triage, compliance reporting, and full-cycle drug safety evaluations.
- Implemented a performance-driven training program, guiding team progression from validation to production.
- Produced high-level regulatory documents (PADERs, PSURs, DSURs, Annual Safety Reports) in adherence with global health authority guidelines and FDA inspections.
- Coordinated with regulatory affairs, clinical research, and medical affairs teams to ensure data integrity and regulatory compliance in drug safety operations.
- Conducted comprehensive weekly evaluations of literature articles to identify potential associations with adverse drug events and ensure rigorous analysis.
- Managed incoming pharmacovigilance data using Argus and ArisG systems, ensuring timely and accurate processing in line with regulatory requirements.
- Developed and delivered company-wide adverse event training programs, focusing on drug-related incidents and reporting standards.
Safety Data Assistant
Bayer Healthcare Pharmaceuticals
Wayne
12.2010 - 05.2011
- Reviewed and quality-checked medical documents, plaintiff fact sheets, and related records for litigation cases involving Bayer male health products.
- Identified potential product complaints, performed coding, and wrote case narratives for adverse events to ensure accurate reporting to Medical Extractors and the FDA.
Clinical Safety Specialist
Merck Pharmaceuticals
Springfield
07.2010 - 12.2010
- Efficiently triaged, collected, monitored, and processed serious and non-serious adverse event reports, ensuring timely distribution to sponsors, regulatory authorities, and project teams.
- Prepared clinical narrative summaries in AERS (Oracle database) and conducted active follow-ups with consumers and healthcare professionals.
- Managed all necessary data entry functions for the safety database.
Drug Safety Associate
Enzon
Bridgewater
03.2010 - 07.2010
- Executed comprehensive database reconciliation, document collection, and query resolution to facilitate the seamless transition of two critical drugs during a corporate acquisition.
- Played an instrumental role in ensuring all data and documentation were accurately aligned and successfully transferred during the transition.
Drug Safety Associate
Novartis Pharmaceuticals
East Hanover
01.1999 - 01.2008
- Expedited electronic submission of 15-day post-marketing and 7-day IND reports.
- Oversaw the transition and outsourcing of critical departmental functions, ensuring seamless continuity and adherence to regulatory standards throughout the process.
- Directed the reconciliation of safety information to maintain compliance, guaranteeing accurate data transfer and alignment during the transition.
Clinical Research Associate
Kendle International
Lawrenceville
01.1997 - 01.1999
- Traveled nationally to monitor clinical trial sites for major pharmaceutical companies, conducting pre-study qualifications, initiation visits, on-site monitoring, and close-out audits, while ensuring the accuracy of medical data and reporting protocol violations.
Education
MSSO MedDRA User Group Training -
MedDRA
Cambridge, MA01.2023
Pharmacy Technician Certification -
Montgomery College
Germantown, MD01.2018
Clinical Research Associate Training -
American Institute of Pharmaceutical Technology
South Plainfield, NJ01.2010
Skills
- Pharmacovigilance oversight
- Safety framework development
- Regulatory compliance
- Adverse event management
- Cross-functional collaboration
- Risk assessment
- Data management
- Team development
- Training leadership
- Technical proficiency: MedDRA
- Technical proficiency: WHO Drug Dictionary
- Technical proficiency: Argus
- Technical proficiency: ArisG
- Technical proficiency: Microsoft Office
Professional Development And Certifications
- Pharmacy Technician Certification, Montgomery College, Germantown, MD, 2018
- MSSO MedDRA User Group Training, MedDRA, Cambridge, MA, 2023
- Conference on AI / Drug Safety / Signal Detection, World Drug Safety Congress Americas, 2023
- Clinical Research Associate Training, American Institute of Pharmaceutical Technology, South Plainfield, NJ, 2010
- Various Training Courses & Seminars, Conducted by the Drug Information Association, 2016
Technical Acumen
- MedDRA
- WHO Drug Dictionary
- Argus
- ArisG
- Word
- Excel
- Outlook
- PowerPoint
Coursework
- Introduction to Regulatory Affairs
- Clinical Safety/ Pharmacovigilance
- Overview of Drug Development
- Introduction of Good Clinical Practices & Auditing
- Adverse Event Criteria
- Reporting to the FDA
Timeline
Manager of Drug Safety
Leadiant Biosciences, Inc.
07.2012 - Current
Safety Data Assistant
Bayer Healthcare Pharmaceuticals
12.2010 - 05.2011
Clinical Safety Specialist
Merck Pharmaceuticals
07.2010 - 12.2010
Drug Safety Associate
Enzon
03.2010 - 07.2010
Drug Safety Associate
Novartis Pharmaceuticals
01.1999 - 01.2008
Clinical Research Associate
Kendle International
01.1997 - 01.1999
MSSO MedDRA User Group Training -
MedDRA
Pharmacy Technician Certification -
Montgomery College
Clinical Research Associate Training -
American Institute of Pharmaceutical Technology
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