Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Meagan Riel-Boardley

Linesville,PA

Summary

Professional leader with extensive experience in driving strategic initiatives and fostering effective team collaboration. Strong background in project management, budget oversight, and stakeholder engagement, ensuring organizational goals are met efficiently. Known for adaptability, reliability, and focus on achieving impactful results. Skilled in leveraging data-driven insights, optimizing processes, and mentoring teams to excel in dynamic environments.

Overview

24
24
years of professional experience
1
1
Certification

Work History

Associate Director, Safety & Pharmacovigilance

Syneos Health
10.2021 - 08.2025
  • Acted as primary liaison between company, sponsors, vendors, and internal departments regarding Safety and Pharmacovigilance operations.
  • Held full line management responsibilities for Safety and PVG staff, including hiring, training, mentoring, performance management, professional development, and terminations.
  • Provided operational oversight of functional teams and projects, ensuring delivery within scope, timelines, and quality standards outlined in Safety Management Plans (SMPs).
  • Monitored team performance and efficiency; addressed underperformance issues with senior leadership and implemented improvement plans.
  • Oversaw Safety-led projects, ensuring compliance with contractual obligations, budget parameters, and sponsor expectations.
  • Reviewed and managed study budgets, ensuring alignment with project scopes. Collaborated with Finance to process customer invoicing and approved project-related timecards and billing.
  • Delivered regular project updates to sponsors, served as a point of escalation, and ensured resolution of sponsor concerns in a timely and professional manner.
  • Collaborated with cross-functional departments to ensure timely and compliant submission of safety reports and resolution of operational issues.
  • Led departmental oversight activities, including SOP development, review, and approval. Evaluated processes for efficiency and effectiveness, and drove continuous improvement initiatives across Safety and PVG functions.
  • Contributed to strategic business development: supported proposal development, reviewed and approved Safety content, participated in bid defenses, and engaged with clients to win new business.
  • Participated in review and approval of Safety sections in protocols and CRFs, ensuring alignment with Serious Adverse Event (SAE) documentation and regulatory requirements.
  • Reviewed and approved drug safety components of project proposals to ensure accuracy and feasibility.
  • Identified and escalated resource needs for Safety services to senior management to ensure adequate staffing and workload distribution.
  • Represented Safety and Pharmacovigilance in cross-functional project team meetings and external client engagements.

Safety & PV Project Delivery Manager

Syneos Health
05.2021 - 10.2021
  • Held full line management responsibilities including staff hiring, transfers, utilization, terminations, training, performance appraisals, job description creation, timesheet approval, professional development, and employee counseling.
  • Assigned project work and managed workload distribution across team members; provided clear guidance on organizational goals and alignment with company objectives.
  • Monitored team performance and quality of deliverables within contracted scope and the Safety Management Plan (SMP); escalated project risks or below-target performance to Associate Director/Director/VP as appropriate.
  • Managed Safety and Pharmacovigilance projects end-to-end, ensuring all contractual, budgetary, and operational requirements were met.
  • Reviewed study budgets and tracked expenses; worked closely with Finance to ensure accurate and timely customer invoicing. Approved timecards and project billing documentation.
  • Delivered scheduled project updates to sponsors and ensured proactive communication and issue resolution.
  • Supported departmental leadership in managing operations, including SOP development and compliance (company and sponsor-specific).
  • Ensured timely and compliant execution of Safety Management Plans and Safety Reporting Plans.
  • Identified areas for process improvement; proposed and implemented efficiency and quality enhancements across Safety and PVG functions.
  • Contributed to business development by reviewing and advising on the safety portions of project proposals, ensuring they accurately reflected scope and deliverables.
  • Reviewed and approved clinical safety components of study protocols and Case Report Forms (CRFs) to ensure consistency and compliance with regulatory standards.
  • Maintained in-depth knowledge of global safety regulations, GCP, ICH guidelines, SOPs, Work Instructions (WIs), and the overall drug, biologic, and device development process.
  • Acted as a resource to staff on administrative procedures, technical challenges, and workload prioritization.

Safety & PV Project Delivery Lead

Syneos Health
11.2020 - 05.2021
  • Served as the primary Safety Specialist for multiple clinical trial and post-marketing projects, with a key focus on delivering comprehensive safety and pharmacovigilance services to a high-priority sponsor across all safety-related activities.
  • Provided strategic leadership and oversight for both clinical trial and post-marketing safety programs, ensuring consistent communication, process alignment, and operational excellence.
  • Acted as the main point of contact for safety-related matters with the sponsor, fostering strong relationships and ensuring timely resolution of issues and delivery of project milestones.
  • Managed multiple concurrent studies, including initiation, safety oversight, and ongoing operational coordination across complex, multi-project environments.
  • Led startup activities and ensured smooth transitions from project award to full-scale operations, while maintaining compliance with regulatory and sponsor-specific requirements.
  • Acted as a central resource for cross-functional teams, ensuring harmonization of safety processes and successful execution of project deliverables.

Associate Safety Manager

IQVIA Biotech
08.2020 - 11.2020
  • Performed end-to-end collection, processing, and reporting of adverse events and clinical endpoints, in full compliance with data protection regulations, HIPAA, Good Clinical Practices (GCP), applicable regulatory guidelines, and study-specific procedures.

Manager, Safety/Pharmacovigilance

Syneos Health
01.2018 - 07.2020
  • Held full line management responsibilities including staff hiring, transfers, utilization, terminations, training, performance evaluations, job description development, timesheet approvals, and employee counseling.
  • Assigned project tasks and managed workload distribution across direct reports; provided oversight and alignment with organizational goals and strategic objectives.
  • Monitored quality and efficiency of team deliverables against contracted scope and Safety Management Plans (SMPs); escalated below-target performance metrics to senior leadership (Associate Director/Director/VP) for corrective actions.
  • Led and managed projects where Safety and Pharmacovigilance were the core services, ensuring operational execution met all regulatory and contractual obligations.
  • Reviewed study budgets and monitored expenses to ensure compliance with financial agreements; addressed any deviations to maintain project and fiscal integrity.

Principal Safety Specialist

INC Research
04.2016 - 12.2017
  • Served as the primary Safety Specialist for multiple clinical trial and post-marketing projects, with a strong focus on providing comprehensive safety and pharmacovigilance services to a high-priority sponsor across all safety-related activities.
  • Provided leadership and oversight for safety deliverables, ensuring consistency, compliance, and alignment of processes and communications across projects.
  • Acted as the main point of contact for the sponsor on assigned studies, managing expectations and ensuring timely issue resolution.
  • Oversaw the management and coordination of complex, multi-study programs, including startup activities and ongoing operational tasks, ensuring successful execution across all phases.

Senior Safety Specialist

INC Research
11.2010 - 04.2016
  • Performed all aspects of adverse event and endpoint collection, processing, and reporting in compliance with data protection regulations, HIPAA, GCPs, regulatory requirements, and study-specific procedures.
  • Led or provided oversight for multiple projects of varying complexity, ensuring timely and high-quality execution of safety deliverables.
  • Managed the daily workload of Safety Specialists within the department, exercising limited line management responsibilities.
  • Mentored and trained junior team members, supporting their professional development and ensuring consistency in safety operations.
  • Acted as a decision-maker for project-related issues, ensuring alignment with regulatory expectations and sponsor requirements.
  • Supported business development efforts by contributing subject matter expertise and delivering presentations to prospective clients.

Senior Safety Specialist

PPD Wilmington North Carolina USA
03.2008 - 11.2010
  • Performed comprehensive collection, processing, and reporting of adverse events and clinical endpoints in strict adherence to data protection regulations, HIPAA, Good Clinical Practices (GCPs), regulatory guidelines, and study protocols.
  • Led and provided oversight for multiple clinical trial and post-marketing safety projects of varying complexity, ensuring timely and high-quality deliverables.
  • Managed daily task allocation and workload distribution for Safety Specialists, with limited line management responsibilities.
  • Mentored and trained junior Safety Specialists, supporting knowledge development, consistency in safety reporting, and team performance.
  • Acted as a key decision-maker for operational safety matters, maintaining compliance with regulatory and sponsor requirements.
  • Contributed to business development initiatives by delivering presentations and providing subject matter expertise in safety and pharmacovigilance operations.

Safety Specialist

PPD Wilmington North Carolina USA
06.2006 - 02.2008
  • Performed end-to-end collection, processing, and reporting of adverse events and clinical endpoints in full compliance with data protection regulations, HIPAA, Good Clinical Practices (GCPs), applicable regulatory guidelines, and study-specific procedures.
  • Led or provided oversight for both clinical trial and post-marketing safety projects, ensuring quality, compliance, and timely execution.
  • Managed the daily workload of Safety Specialists for projects of moderate to high complexity, ensuring balanced task distribution and adherence to project timelines.

RN

New Hanover Regional Medical Center Wilmington NC USA
08.2001 - 06.2006
  • Provided management oversight for night shift operations across a 25-bed telemetry unit and a 10-bed open-heart surgery unit.
  • Coordinated staff scheduling to ensure adequate coverage and optimal patient care delivery.
  • Assisted in the development and implementation of departmental policies and procedures to support quality and compliance standards.
  • Designed and delivered staff training programs to improve clinical skills, safety practices, and overall performance.
  • Delivered direct patient care to cardiac patients, ensuring high standards of clinical excellence and compassionate care.

Education

Bachelor - Nursing

University of Pittsburgh
01.2001

Skills

  • InForm EDC proficiency
  • Proficient in Rave EDC
  • Proficient in MedDRA
  • Experience with Power BI
  • Experience with Trial Interactive
  • Veeva Vault expertise
  • Experience with Vault Clinical
  • Expertise in Argus Safety Database
  • Proficient in ArisGlobal
  • Veeva Safety Database

Certification

  • Acquired Date: 09-MAR-2011
  • Expiration Date: 30-APR-2026
  • Certification or Licensure: Pennsylvania nursing license

Languages

English
Native or Bilingual

Timeline

Associate Director, Safety & Pharmacovigilance

Syneos Health
10.2021 - 08.2025

Safety & PV Project Delivery Manager

Syneos Health
05.2021 - 10.2021

Safety & PV Project Delivery Lead

Syneos Health
11.2020 - 05.2021

Associate Safety Manager

IQVIA Biotech
08.2020 - 11.2020

Manager, Safety/Pharmacovigilance

Syneos Health
01.2018 - 07.2020

Principal Safety Specialist

INC Research
04.2016 - 12.2017

Senior Safety Specialist

INC Research
11.2010 - 04.2016

Senior Safety Specialist

PPD Wilmington North Carolina USA
03.2008 - 11.2010

Safety Specialist

PPD Wilmington North Carolina USA
06.2006 - 02.2008

RN

New Hanover Regional Medical Center Wilmington NC USA
08.2001 - 06.2006

Bachelor - Nursing

University of Pittsburgh