Experienced healthcare professional dedicated to delivering exceptional patient care and upholding clinical standards. Skilled in fostering a collaborative environment for optimal patient outcomes. Recognized for reliability, adaptability, and effective teamwork. Excellent communication skills for clear and efficient interactions with patients and colleagues.
Overview
2025
2025
years of professional experience
1
1
Certification
Work History
ER Staff Nurse
St. Joseph's Health Center
Trauma Nurse responsible for patient care and collaboration with team members
Administered medications via oral, IV, and intramuscular injections and monitored responses.
Assisted physicians with diagnostic procedures, ensuring accurate results for optimal treatment planning.
Used first-hand knowledge and clinical expertise to advocate for patients under care and enacted prescribed treatment strategies.
Documented treatments delivered, medications and IVs administered, discharge instructions, and follow-up care.
Exhibited strong critical thinking skills when assessing complex medical situations and determining appropriate interventions.
Evaluated the effectiveness of care plans regularly, making adjustments as needed based on individual patient needs and progress toward goals.
Assessed physical, psychological, physiologic, and cognitive status of patients.
Lead, Operations QA & Compliance
WCG Clinical
09.2021 - 07.2024
Organized, led, and managed both internal and external audits, including those with business partners and the FDA, and supported business partners during regulatory audits and inspections
Led, supported, and reported independent GCP audits according to and for assigned operational services, quality systems, Good Clinical Practice (GCP), and current international and national regulations
Provided GCP-related quality guidance and assisted in the identification and implementation of quality assurance needs for Global GCP Audits and other Business partners across GCP disciplines, including internal and external objectives
Supported and led audit inspection activities with PV, acting as both a subject matter expert (SME) and a support figure
Led and held responsibility for the implementation and delivery of global cross-functional compliance audit programs to ensure the operational services functions, processes, and systems offered to customers follow standards and regulatory requirements
Collaborated with leadership to achieve corporate QA and Compliance goals, ensuring the services adhered to the Quality Management System and business processes
Developed and enforced quality standards across departments, establishing frameworks that met regulatory requirements and incorporated industry best practices, principally for the Learning Management Systems
Drove continuous improvement by monitoring and evaluating systems and processes, serving as a change agent
Continuously assessed and improved practices to ensure operational excellence and compliance with regulations
Maintained and updated critical documentation, including division risk registers, and led monthly meetings to revise departmental policies and procedures
Sr. Drug Safety Specialist
Nektar Therapeutics
11.2018 - 02.2020
Served as a key member of the Drug Safety team, providing expertise, support, and training, collaborating with teams and health care professionals to ensure trial safety
Presented at pharmacovigilance meetings at all organizational levels to maintain high safety levels for trial subjects
Managed quality control, case triage, and follow-up on serious adverse event reports
Mentored drug safety team members and represented the department at Investigator meetings
Ensured the accuracy and regulatory compliance of individual case reports
Conducted electronic case assessments, including triage and expedited report determinations
Processed cases, including data entry, narrative writing, quality control, and timely reporting
Created monthly PowerPoint summaries of study metrics, compliance risks, and action plans
Reviewed and resolved discrepancies in monthly SAE reconciliations and led meetings to align actions with Clinical Operations
Developed, implemented, and facilitated revamped and engaging training for the Argus Safety Database
Monitored and escalated expedited safety reporting compliance issues due to drug safety expertise
Promoted and retained through acquisition due to expertise, communication skills, and work ethic
Conducted audits of internal processes to identify areas for improvement in overall safety performance.
Organized regular meetings with cross-functional teams to discuss ongoing safety initiatives, challenges, and opportunities for improvement.
Pharmacovigilance Specialist
Labcorp (formerly Theorem/Chiltern/Covance)
06.2014 - 08.2017
Reviewed and processed Lifecycle Safety data across all service lines, ensuring distribution of reports/data to internal and external parties in compliance with regulations, SOPs, and guidelines, supported by senior operations team members
Managed the receipt, triage, review, and processing of data from diverse sources, ensuring timeliness and quality standards
Executed data entry, medical terminology coding, narrative writing, query generation, quality control, reconciliation, case closure, and timely report delivery to customers
Supported operations team, including backup support, status report generation, project metrics provision, drafting instructions/guidelines, and new process implementation
Utilized expertise multiple times in temporary assignments or contract roles for Chiltern (and its acquired companies), multiple times due to pharmacovigilance expertise and communication skills
Sr. Pharmacovigilance Analyst
AbbVie (formerly Allergan)
06.2010 - 12.2014
Conducted safety surveillance and provided pharmacovigilance expertise for marketed and investigational products
Prepared and processed AE and SAE reports, collaborating with cross-functional teams and external partners
Reviewed and contributed to updates of departmental SOPs
Contributed to FDA Audit preparation, with audited cases being 100% compliant
Served as an SME for ICSR follow-ups during a mock MHRA audit and mentored Global Safety and Epidemiology colleagues
Led the creation of and training on an advanced narrative template for AE and SAE reports, earning a VIP award for efforts
Designed a new-hire training tool in collaboration with a focus group, enhancing onboarding
Developed a checklist for processing ICSRs involving serious or SAEs
Completed reconciliation for a major Allergan safety study in partnership with a CRO managing the EDC platform