Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Savar McRae

Holly Springs,NC

Summary

Highly-motivated and committed healthcare professional with desire to take on new challenges and a history of meeting company needs with consistent and organized practices. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Experienced in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Operations Specialist 2

IQVIA
Durham, NC
10.2023 - Current
  • Provides comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements
  • Collects, tracks, and reports adverse events or clinical outcomes; analyzes and reports aggregate safety data; performs safety surveillance; and performs benefit-risk evaluation and planning

Senior Safety Specialist Lead

IQVIA Biotech
Durham, NC
10.2021 - 10.2023
  • Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures
  • Primary responsibilities include processing and reporting of incoming safety events and related data
  • Serves in a mentorship/leadership role, including Safety Management Lead on moderate to large sized studies/programs that are moderate to complex in scope of work

Operations Specialist 2

IQVIA
Durham, NC
01.2021 - 10.2021
  • Processing of reports including case intake, tracking, data entry, and query generation within Apex, Argus, and Rave EDC.
  • Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events
  • Database entry, coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines.
  • Creating, maintaining and tracking cases as applicable to the project plan.
  • Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
  • Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
  • Ensure to meet quality, productivity and delivery standards per project requirements.
  • Ensure compliance to all project related processes and activities.
  • Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
  • Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
  • Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
  • Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned project.
  • Set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
  • Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes

Operations Specialist 2

PPD
11.2016 - 01.2021
  • Provide department training and mentoring of Safety Specialists and new employees; in addition to new procedures or procedures that require review
  • Maintain knowledge and understanding of PPD SOPs; current local and global regulations regarding clinical trials, regulatory documents and safety issues
  • Reconcile data listings between the clinical/safety database(s)
  • Review compliance of expedited safety reporting on assigned project and escalate problems or issues to PVG manager
  • Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities
  • Code adverse event terms and write narratives according to client convention
  • Provide training, mentoring and work direction to more junior level staff, and quality review of data, including SAE and AE reports
  • Maintain knowledge and understanding of PPD and client-provided SOPs and current and local global regulations
  • Effectively communicate with team members, client contact and adverse event reporters.

Safety Specialist

PPD
12.2014 - 11.2016
  • Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, coding, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports and reporting activities
  • Was responsible for adhering to PPDs corporate policies, SOPs/WPDs, and awareness of ICH GCP guidelines and other relevant global and local regulations
  • Effectively interfaced with Project Teams and Client companies regarding SAE activities
  • Maintained general understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required for processing SAEs
  • Was responsible for coordinating and performing SAE/AE triage, data entry into PPD-owned or client provided AE database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities
  • Coded adverse events and write narratives according to client convention
  • Maintained knowledge and understanding of PPD and client-provided SOPs and current local and global regulations
  • Effectively communicated with team members, client contacts and adverse event reporters.

Consultant Nurse

PPD
09.2012 - 12.2014
  • Provided medical and drug information with high quality customer service, including researching and responding to inquiries over the phone and/or the internet and documenting appropriately according to company and project guidelines
  • Responsibilities also included identifying and recording adverse events and product complaints, as well as processing fulfillment.

Registered Nurse

WakeMed Health and Hospitals
03.2010 - 09.2012
  • Performed as an intraoperative circulator/scrub nurse for Orthopedic, General, Urological, Gynecological and Robotic Surgeries
  • Served as a preceptor for new orientees
  • Maintained knowledge of surgical technique and competencies guided by the Association of Operating Room Nurses
  • Demonstrated independent, objective problem-solving skills as well as good communication and interpersonal skills to provide optimal patient care.

Nurse Aide

WakeMed Health and Hospitals
10.2008 - 03.2010
  • Provided direct patient care under the supervision of a staff nurse including assisting with activities of daily living such as bed positioning, maintaining patients' daily hygiene, toileting, feeding, and obtaining vital signs (blood pressures, heart rate, respirations, blood glucose levels) and reporting any abnormalities to the supervising staff nurse
  • Maintained required licensing with the NC Board of Nursing
  • Clinical Trial Experience
  • Study Phase:
  • Phase 1
  • Indication:
  • Solid Tumor Configuration

Education

Associate of Applied Science - Nursing

Wake Technical Community College
Raleigh, NC
12.2009

Medical Assistant

Bryman College
New Orleans, LA
01.1998

Skills

  • Process Documentation
  • Operational Efficiency
  • Planning and Coordination
  • Cross-Functional Communication
  • Safety Documentation and Materials
  • Safety Training
  • HIPAA Compliance
  • Patient Positioning
  • Teamwork and Collaboration
  • Patient Charting
  • Critical Thinking
  • Decision-Making
  • Patient Safety

Certification

  • NC Board of Nursing License #236364, 2010 exp 30Jun2025

Timeline

Operations Specialist 2

IQVIA
10.2023 - Current

Senior Safety Specialist Lead

IQVIA Biotech
10.2021 - 10.2023

Operations Specialist 2

IQVIA
01.2021 - 10.2021

Operations Specialist 2

PPD
11.2016 - 01.2021

Safety Specialist

PPD
12.2014 - 11.2016

Consultant Nurse

PPD
09.2012 - 12.2014

Registered Nurse

WakeMed Health and Hospitals
03.2010 - 09.2012

Nurse Aide

WakeMed Health and Hospitals
10.2008 - 03.2010

Associate of Applied Science - Nursing

Wake Technical Community College

Medical Assistant

Bryman College

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Savar McRae