Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
BusinessDevelopmentManager
Elysia DeVera

Elysia DeVera

Senior Pharmacovigilance Associate
Plainwell,MI

Summary

Highly knowledgeable Senior Pharmacovigilance Associate with significant background in Global Patient Safety. Familiarity with global regulatory requirements, database input, and report writing for adverse events. Strengths include strong analytical skills, ability to work collaboratively within cross-functional teams, and keen eye for detail. Previous roles within the department have led to improved safety measures and effective implementation of pharmacovigilance processes.

Overview

15
15
years of professional experience

Work History

Senior Pharmacovigilance Associate

Perrigo Company
Allegan
01.2010 - Current
  • Processed and finalized individual case safety reports (ICSRs).
  • Triage of formula cases in TrackWise
  • Acquired license partner batch numbers using the SAP system.
  • Creation of legal cases within the TrackWise data base
  • Narrative writing
  • Oversaw daily case allocation within TrackWise.
  • Executed listedness calls efficiently.
  • Conducted monthly reconciliations with various license partners.
  • Compiled detailed monthly reports for PV department.
  • Incorporated precise medical terminology into daily tasks.
  • Facilitated editing and timely submission of PADER/aggregate reports to FDA.
  • Ensured accurate coding of all medical history, adverse events, and drugs.
  • Ensured alignment with medical coding standards by referencing MedDRA and WHO-DD guidelines.
  • Conducted peer reviews and quality checks of ANDA cases.
  • Entered data for clinical trial reports.
  • Input literature reports into database.
  • Monitored testing procedures to meet established item specifications, standard test methods or protocols.
  • Followed confidentiality rules to preserve data quality and reduce potential information compromise.
  • Participated in risk management plan meetings with internal stakeholders and external partners.
  • Provided guidance on appropriate coding conventions for adverse event terms used in medical records.
  • Assisted in the preparation of training materials related to pharmacovigilance best practices.
  • Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
  • Collaborated with internal teams to ensure timely completion of safety data collection activities.
  • Reviewed adverse drug reaction reports from healthcare professionals and patients to determine causality.
  • Adhered to good clinical practices, operating procedures and regulatory requirements.
  • Maintained up-to-date knowledge of applicable FDA regulations governing drug safety reporting requirements.
  • Performed quality assurance reviews of case processing activities.
  • Analyzed issues and recommended corrective actions to improve final results.
  • Prepared written summaries of findings from pharmacovigilance investigations for regulatory submission purposes.
  • Contributed innovative ideas and solutions to enhance team performance and outcomes.
  • Provided support and guidance to colleagues to maintain a collaborative work environment.
  • Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
  • Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
  • Completed day-to-day duties accurately and efficiently.
  • Worked with cross-functional teams to achieve goals.
  • Conducted system analysis and testing to identify and resolve technical issues or inefficiencies.
  • Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
  • Maintained updated knowledge through continuing education and advanced training.
  • Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
  • Utilized various software and tools to streamline processes and optimize performance.
  • Worked effectively in team environments to make the workplace more productive.

Medical Office Assistant

Wings of Hope Hospice
Allegan
06.2010 - 07.2010
  • Facilitated weekly meeting organization.
  • Handled incoming phone calls and managed email responses.
  • Handled billing processes using QuickBooks.
  • Communicated effectively with other healthcare staff members regarding patient care plans.
  • Interviewed patients to complete case histories and intake forms.
  • Communicated with patients with compassion while keeping medical information private.
  • Transmitted medical records and other correspondence by mail, e-mail, or fax.
  • Completed and safeguarded medical records, securing patient information to maintain confidentiality.
  • Followed HIPAA guidelines to ensure confidentiality of patient information.
  • Prepared reports, invoices, letters, or medical records using word processing, spreadsheet, or other software applications.
  • Answered telephones and directed calls to appropriate medical or adminstrative staff.
  • Performed basic clerical duties such as filing documents, entering data into the computer system, photocopying forms and documents.

Home Health Aide

Heritage Community
Portage
08.2005 - 10.2008
  • Obtain patient vitals
  • Help residents with activities of daily living
  • Distribution of daily medications
  • Provided emotional support to clients dealing with chronic illnesses or end-of-life situations.
  • Assisted in ambulation and exercise routines for clients.
  • Organized and administered medications on schedules to alleviate symptoms and improve quality of life.
  • Improved patient outlook and daily living through compassionate care.
  • Cared for patients by assisting with personal hygiene tasks and completing basic household chores.
  • Monitored vital signs such as temperature, pulse rate, blood pressure .
  • Administered prescribed medications under direction from physician.
  • Answered patient calls promptly, providing assistance or referring them to appropriate personnel when needed.
  • Took initiative to ensure all tasks were completed efficiently within the designated time frame.
  • Planned, prepared or served meals to patients according to prescribed diets.
  • Helped clients move in bed, stand or walk using proper body mechanics techniques.
  • Accompanied clients to doctors' offices or on other trips outside home.
  • Provided patients and families with emotional support and instruction.
  • Documented patient status and reported changes in care needs.
  • Maintained confidentiality of patient information at all times as per HIPAA regulations.
  • Documented care provided and submitted notes to supervisor.
  • Engaged patients in recreational activities such as reading books or playing games.
  • Recorded daily notes about client conditions, treatments provided and progress made.

Education

Medical Administration Assistant - Health Administration

Everest Institute
Kalamazoo, MI
10.2008

Some College (No Degree) - Health Care Administration

Baker College
Flint, MI

Skills

  • Strong organizational skills
  • Time management skills
  • Exceptional communication skills
  • Interpersonal skills
  • Ability to work independently
  • Ability to work as part of a team
  • Detail-oriented
  • Ability to handle multiple tasks simultaneously
  • MS Office
  • MS Excel
  • Regulatory compliance
  • Team lead
  • Follows Standard Operating Procedures
  • Seasoned remote work
  • LEAN SIGMA Yellow Belt Certified
  • Top case processor on pharmacovigilance associate team
  • Continuous learning mindset
  • Case processing
  • Cross-functional coordination
  • Drug safety expertise
  • Medical terminology
  • Adverse event reporting
  • Pharmacovigilance regulations
  • Patient safety assessment
  • Drug labeling review
  • Good clinical practice
  • Drug safety monitoring
  • Medical writing
  • MedDRA coding

Accomplishments

Top case processor on pharmacovigilance associate team

Timeline

Medical Office Assistant

Wings of Hope Hospice
06.2010 - 07.2010

Senior Pharmacovigilance Associate

Perrigo Company
01.2010 - Current

Home Health Aide

Heritage Community
08.2005 - 10.2008

Medical Administration Assistant - Health Administration

Everest Institute

Some College (No Degree) - Health Care Administration

Baker College

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Elysia DeVeraSenior Pharmacovigilance Associate