Drug Safety Data Analysis

ANGELA M. DAVIDSON RN, BSN 314-***-**** **********@*******.*** LinkedIn: www.linkedin.com/in/angeladavidsonrn

DRUG SAFETY & PHARMACOVIGILANCE CONSULTANT QUALITY INTEGRITY EXCELLENCE

Experienced and dependable Pharmacovigilance Consultant with a keen focus on safety and compliance and a proven track record implementing streamlined operational solutions. Strong interpersonal and communication skills that foster cooperation and collaboration among cross-functional teams and stakeholders. Accomplished in monitoring, processing, and reporting the adverse event data obtained from clinical trials and other sources while also ensuring data accuracy and consistency. Accurate and timely reporting of collected data in company databases as per applicable standards, regulations, and guidelines while meeting project milestones and timelines in line with pharmacovigilance project budgets. Participates in client meetings and contributes to the discussion from a pharmacovigilance point of view.

MULTIPLE HIGH-LEVEL SYSTEMS EXPERIENCE: MS Office Suite, Argus Safety Database, Veeva Vault Safety Database, Veeva Vault TMF, Oracle AERs, Clintrace, MedDRA, WHODrug, Phase Forward InForm Electronic Data Capture, Datalabs, Merge, Medidata/RAVE, Trackwise Enterprise Quality Management System, ePharmaOne, Adobe Acrobat, and Foxit Phantom PDF

PROFESSIONAL EXPERIENCE:

WCG CLINICAL – Lead, Operations QA & Compliance August 2021 to July 2024

- Successfully organized, led, and managed comprehensive internal and external audits, including collaborations with business partners and the FDA, while actively supporting partners during crucial regulatory audits and inspections.

- Expertly conducted independent Good Clinical Practice (GCP) audits tailored to assigned operational services and quality systems, ensuring strict adherence to both international and domestic regulations.

- Delivered strategic GCP-related quality guidance and played a pivotal role in identifying and implementing essential quality assurance needs for Global GCP Audits and various business partners across GCP disciplines, aligning internal and external objectives seamlessly.

- Spearheaded audit inspection activities alongside pharmacovigilance (PV) teams, serving as a trusted subject matter expert (SME) and providing invaluable support throughout the process.

- Championed the implementation of robust pharmacovigilance processes, guaranteeing compliance with Good Vigilance Practice (GVP) guidance documents, which led to significantly improved outcomes in regulatory audits.

- Assumed full responsibility for the development and execution of global cross-functional compliance audit programs, ensuring that all operational services, processes, and systems not only met but exceeded industry standards and regulatory requirements.

- Collaborated effectively with leadership to drive corporate Quality Assurance (QA) and Compliance goals, ensuring that services delivered by Research & Review Solutions (RSS) consistently conformed to the Quality Management System and optimal business processes.

- Developed and enforced rigorous quality standards across departments, establishing innovative frameworks that not only meet regulatory requirements but also embrace industry best practices, especially for the Learning Management Systems (LMS).

- Actively fostered a culture of continuous improvement by meticulously monitoring and evaluating systems and processes, positioning myself as a catalyst for positive change.

- Proactively assessed and refined practices to ensure sustained operational excellence and unwavering compliance with regulations.

- Maintained and updated critical documentation, including division risk registers, while leading monthly meetings to review and enhance departmental policies and procedures for optimal effectiveness.

NEKTAR THERAPEUTICS November 2018 to February 2020

Sr. Drug Safety Specialist: Nektar (2019 to 2020)

- Actively contributed as a key member of the Drug Safety team, providing expert support and training while collaborating effectively with teams and healthcare professionals to ensure the utmost safety of trial subjects.

- Delivered impactful presentations at various organizational levels during pharmacovigilance meetings, upholding and enhancing high safety standards for trial participants.

- Led quality control efforts, efficiently managed case triage, and ensured thorough follow-up on serious adverse event reports.

- Mentored and developed the skills of fellow drug safety team members, representing the department with authority at investigator meetings.

- Ensured the highest levels of accuracy and regulatory compliance in individual case reports.

- Conducted comprehensive electronic case assessments, including precise triage and expedited report determinations.

- Expertly processed cases, encompassing data entry, narrative writing, quality control, and timely reporting.

- Created and presented monthly PowerPoint summaries that highlighted study metrics, compliance risks, and actionable plans.

- Reviewed and expertly resolved discrepancies in monthly serious adverse event (SAE) reconciliations, leading meetings that aligned actions with Clinical Operations.

**Notable Achievements: **

- Developed, implemented, and facilitated dynamic and engaging training for the Argus Safety Database, significantly enhancing team capabilities.

- Proactively monitored and escalated compliance issues in expedited safety reporting, leveraging my expertise in drug safety.

- Recognized for contributions and promoted during acquisition, affirming my value to the organization.

Drug Safety Specialist III: PRO Unlimited, Inc. (2018 to 2019)

- Coordinated and supported contracted safety tasks, serving as a subject matter expert (SME), mentor, and liaison within the department.

- Managed case triage, assessments, and reporting, ensuring compliance with safety criteria and expedited reporting timelines.

- Identified and implemented process improvements within the department, enhancing operational efficiency.

**Notable Achievements:**

- Led the "Clean-up" Project for Listedness in the Argus Safety Database.

- Developed PowerPoint slides addressing Serious Adverse Event (SAE) queries and reconciliations for a key roundtable meeting in January 2019.

- Authored a Triage Draft Workflow Document to improve processes and update the Triage Standard Operating Procedure (SOP).

- Conducted quality control reviews of SAE data and summarized findings for Global Phase 2-3 Clinical Studies.

- Appointed as the Pharmacovigilance Study Lead for a Phase 2 Bladder Cancer Clinical Study during its start-up phase.

LABCORP (formerly Theorem/Chiltern/Covance) June 2014 to December 2018

Pharmacovigilance Specialist: Chiltern (2018)

- Reviewed and processed Lifecycle Safety data across all service lines, ensuring the distribution of reports and data to internal and external parties in compliance with regulations, standard operating procedures (SOPs), and guidelines, with support from senior operations team members.

- Managed the receipt, triage, review, and processing of data from diverse sources, ensuring adherence to 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.

- Provided support to the operations team by offering backup assistance, generating status reports, supplying project metrics, drafting instructions and guidelines, and implementing new processes.

**Notable Achievement:**

- Frequently utilized expertise in temporary assignments or contract roles for Chiltern (and its acquired companies) due to my strong background in pharmacovigilance and effective communication skills.

Pharmacovigilance Professional II: Chiltern (2016 to 2017)

- Conducted Quality Control (QC), case triage, analysis, and follow-up on Serious Adverse Event (SAE) reports across multiple clinical trials.

- Managed budgetary responsibilities for pharmacovigilance projects, overseeing revenue recognition and contract adjustments.

- Maintained up-to-date internal records, including timesheets, expense claims, and productivity reports.

**Notable Achievements:**

Played a pivotal role in the global pharmacovigilance team, serving as a Subject Matter Expert (SME) and mentor for new and junior members while ensuring high-level trial subject safety through collaboration with cross-functional teams and healthcare professionals.

- Represented the pharmacovigilance team at Investigator Meetings, providing essential training on study-specific responsibilities to clients and site teams. - Led both partial and full-service pharmacovigilance projects, including the creation and updates of Safety Management Plans for global clinical trials (Phase 1-3), and managed User Acceptance Testing for safety databases.

Safety Officer 1: Theorem (Contract via BioPoint) (2014 to 2015)

- Utilized specialized expertise to perform data management reviews for various clinical research studies, ensuring the integrity of the data.

- Evaluated clinical trial data following safety data management plans and standardized procedures to address discrepancies.

- Oversaw the generation, resolution, and tracking of queries related to data reconciliation issues.

- Delivered regular project updates to the Project Team Manager, maintaining clear communication and ensuring alignment throughout the project.

ABBVIE (formerly Allergan) – Sr. Pharmacovigilance Analyst June 2010 to December 2014

- Conducted safety surveillance and provided pharmacovigilance expertise for both marketed and investigational products.

- Prepared and processed adverse event (AE) and serious adverse event (SAE) reports while collaborating with cross-functional teams and external partners. Reviewed and contributed to updates of departmental standard operating procedures (SOPs).

**Notable Achievements:**

- Contributed to the preparation for an FDA audit, with audited cases achieving 100% compliance.

- Served as a subject matter expert (SME) for ICSR follow-ups during a mock MHRA audit and mentored colleagues in Global Safety and Epidemiology. - Led the development and training of an advanced narrative template for AE and SAE reports, earning a VIP award for these efforts.

- Designed a new-hire training tool in collaboration with a focus group, enhancing the onboarding process.

- Developed a checklist for processing Individual Case Safety Reports (ICSRs) involving serious or SAEs.

- Completed reconciliation for a major Allergan safety study in partnership with a contract research organization (CRO) managing the electronic data capture (EDC) platform.

ST. JOSEPH'S HEALTH CENTER – ER Staff Trauma Nurse 2 Years

EDUCATION, TRAINING & CERTIFICATIONS:

SPRING HILL COLLEGE; BSN

State of Missouri (Compact License); RN Compact License April 2025 to Present

Good Clinical Practice (WCG MAGI) ICH E6, Training Version 1.0 May 2023

ISO 9001:2015 Requirements (TPECS) September 2022

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