Angelina Barfield

• Lead enterprise-level safety operations for clinical and post-market products, aligning global case management, reporting compliance, and vendor-delivered activities within a scalable pharmacovigilance framework.
• Built governance models for outsourced and delegated pharmacovigilance activities, including KPI oversight, escalation pathways, reconciliation controls, and compliance monitoring.
• Directed creation and lifecycle management of SDEAs and pharmacovigilance contractual language to support partner, distributor, and vendor relationships across global markets.
• Strengthened aggregate safety review processes by coordinating operational, medical, and regulatory inputs for DSURs, PBRERs, PSURs, and related benefit-risk assessments.
• Implemented training and compliance programs for internal stakeholders, vendors, and commercial teams to reinforce adverse event reporting quality and post-market surveillance obligations.
• Developed structured source-identification methodology for complex vendor reporting environments to improve intake consistency, source attribution, and downstream safety reporting control.
• Self-motivated, with a strong sense of personal responsibility.
• Worked effectively in fast-paced environments.
• Skilled at working independently and collaboratively in a team environment.

Director, Service Operations | Oct 2023 - Oct 2024

Director, Global Safety Reporting | Apr 2019 - Oct 2023

Assoc. Director, Global Safety Reporting | Dec 2017 - April 2019

Senior Manager, Safety Reporting | Jan 2017 - Dec 2017

• Progressed through four leadership roles of increasing scope across safety reporting and service operations, culminating in director-level leadership for Lifecycle Safety Operations and global safety reporting services.
• Built and led global safety reporting capabilities, including establishment of the Safety Reporting function, development of SOPs, work instructions, and templates, and oversight of expedited and periodic reporting to Competent Authorities, Ethics Committees, IRBs, and Investigators.
• Provided strategic and functional oversight of safety reporting staff and services, enhancing operational quality and regulatory compliance while coordinating execution across client programs and internal stakeholders.
• Monitored evolving global safety regulations and translated new guidance into compliant reporting processes and procedural updates, ensuring adherence to regulatory requirements.
• Led implementation of EU CTR and post-Brexit process changes and served as EudraVigilance Responsible Person, including sponsor registration and product registration in XEVMPD.
• Facilitated audit and regulatory inspection readiness, root-cause analysis, and issue resolution using structured problem-solving methods.

Managed drug safety and clinical endpoint adjudication committee projects, including line management.

Delivered services for post-marketing and clinical trial case processing, DSUR/PSUR/PADER/Annual Safety Report development, workflow optimization, sales representative training, safety data exchange agreement development, safety monitoring plan development, and signal detection review and analysis with recommendations for updates to product label/Investigator’s Brochure, as well as developing position papers or analyses for presentation to executive management and/or regulatory authorities.

Supervised/Mentored/Coached US safety team. Streamlined case workflow to increase efficiency/productivity. Advised executive leadership of all legal and regulatory pharmacovigilance requirements in applicable territories worldwide including North/Central/South America, Japan and the EEA. CAPA and root cause analysis. Product complaint processing and tracking. Collaborated with distributors, co-marketing partners, CRO’s, and vendors on the relevant day-to-day aspects of contractual agreements. Prepared aggregate safety reports (PSURs, PADERs, IND Annual Reports, DSURs) and other documents including Investigator Brochures, Summary of Product Characteristics, and Package Inserts.

Pioneered the development of Product Safety as a stand-alone department including establishing a case processing workflow and quality standards/KPIs. Oversight of the day-to-day operations of the Product Safety team including mentoring and coaching of direct reports. Worked independently to establish departmental priorities and direction. Provided safety expertise on cross-functional product/project teams.

Responsible for all day-to-day safety operations. Developed and implemented drug safety and pharmacovigilance working practices and SOPs. Established workflow for processing serious adverse event and medical device reports both internally and with external vendors and drug development partners. Conducted quarterly safety reviews for clinical development compounds. Coordinated and supervised the outsourcing of safety functions including SAE case processing.

Responsible for case processing for clinical trials and post-marketing safety reports. Supervised CROs to ensure deliverables and timelines were met. Prepared and analyzed data for safety submissions (aggregate safety reports, Integrated Safety Summary for NDA submissions). Developed content and presented safety reporting procedures at investigator meetings. Drafted risk/benefit sections of informed consent forms. Analyzed data for the purpose of recommending safety label changes.

Senior Product Surveillance Monitor | Sep 1998 - Feb 2003

Progressed from Clinical Research Scientist to Senior Product Surveillance Monitor, expanding responsibility from clinical trial execution to global safety surveillance and aggregate safety analysis.

• Performed serious adverse event (SAE) case processing for clinical trial programs, ensuring accurate assessment, coding, and documentation to support regulatory reporting and signal evaluation.
• Prepared and analyzed safety data for aggregate submissions, contributing to periodic safety updates and benefit–risk assessments.
• Analyzed safety data to support recommendations for product label changes, bridging clinical trial safety findings with post-approval risk communication needs.
• Managed study start-up and execution activities, including site identification and monitoring, vendor and investigator contract negotiation, and cross-functional planning and tracking of trial timelines.
• Clinical Research Scientist | Jun 1996 - Sep 1998

Clinical Program Manager | Mar 1994 - Jan1995

Clinical Research Associate | Oct 1991 - Mar1994