Pharmacovigilance Specialist Resume Example & Writing Guide

Use this Pharmacovigilance Specialist resume example and guide to improve your career and write a powerful resume that will separate you from the competition.

As a pharmacovigilance specialist, you’ll monitor drug safety to identify potential issues or concerns. You’ll compile reports about adverse reactions, identify trends, and help make recommendations for improvement. And you’ll do all of this while working with a team of other pharmacists and medical experts to maintain a safe and effective medication supply.

If you’re interested in pursuing a career in this field but aren’t sure where to start your resume writing process, here are some tips and an example for reference.

Jennifer Thomas
Los Angeles, CA | (123) 456-7891 | [email protected]

Highly experienced pharmacovigilance specialist with a proven track record in the life sciences industry. Demonstrates expertise in signal detection, case management, and regulatory compliance. Driven to protect public health by ensuring the safe and effective use of medicines.

University of California, Davis Jun '10
B.S. in Biology
Company A, Pharmacovigilance Specialist Jan '17 – Current
  • Conducted clinical and non-clinical pharmacovigilance activities, including the review of safety information on marketed products and post-marketing adverse event reports (AEs).
  • Assessed potential causal relationships between drug exposure and AEs based on available data sources such as spontaneous AE reports, clinical trial data, observational studies, etc.
  • Developed strategies to address safety concerns related to marketed drugs or investigational agents through risk management actions such as labeling changes, medication guide revisions, patient education materials, etc.
  • Provided expert advice regarding the evaluation of new drug applications for safety issues prior to submission to regulatory authorities in Japan.
  • Participated in internal project teams focused on improving processes within Pharmacovigilance department and participated in external committees with other departments at Takeda Pharmaceuticals International AG.
Company B, Pharmacovigilance Specialist Jan '12 – Dec '16
  • Assisted in the development of a new safety program that reduced adverse drug events by 10%
  • Conducted regular reviews of all medical records to identify potential adverse reactions and side effects
  • Reviewed reports from patients, healthcare providers and pharmaceutical companies for adverse event information
  • Analyzed data on patient complaints and reported any possible safety concerns to management
  • Communicated with patients about their medication-related problems or side effects using email and phone calls
Company C, Pharmacovigilance Intern Jan '09 – Dec '11
  • Conducted literature reviews of adverse event reports for assigned drugs to identify potential safety concerns.
  • Evaluated individual case safety reports for completeness and accuracy, and followed up with reporters as needed to obtain missing information.
  • Documented findings in internal databases and prepared summary reports of safety data for review by senior staff.
  • Certified Clinical Research Professional (CCRP)
  • Certified Regulatory Affairs Professional (RAC)
  • Clinical Research Associate (CRA)

Industry Knowledge: Pharmacovigilance, Drug Safety, Medical Writing, Medical Terminology, Medical Coding, FDA, ICH, EudraCT, ICH-GCP, GLP, GCP, GMP, ISO, TGA, TPD, TQ, WADA
Technical Skills: MedDRA, Micromedex, RxNorm, WHO Drug Information, Lexi-Comp, First DataBank, SafetyLit, Lexi-Comp, RxISK, Proteus, Adverse Event Reporting, ICH Harmonization, Data Analysis
Soft Skills: Communication, Leadership, Teamwork, Problem Solving, Critical Thinking, Time Management, Organization, Flexibility

How to Write a Pharmacovigilance Specialist Resume

Here’s how to write a resume of your own.

Write Compelling Bullet Points

Bullet points are the most effective way to showcase your experience and qualifications. And when it comes to bullet points, the more specific and detailed you can be, the better.

For example, rather than saying you “managed drug safety reporting system,” you could say you “managed drug safety reporting system, identifying and correcting data discrepancies in real time to ensure accurate reporting for over 1,000 drugs across 10+ countries.”

The second bullet point is much more specific and provides more detail about what exactly you did and the results of your work.

Identify and Include Relevant Keywords

When you apply for a job as a pharmacovigilance specialist, your resume is likely to be screened by an applicant tracking system (ATS) that looks for certain keywords related to the position. If your resume doesn’t include enough of the right keywords, your application might not make it past the first round of cuts.

The best way to make sure you have the right keywords on your resume is by reading through a few job postings and taking note of the terms and phrases that are used most often. Then, you can strategically add those same words into your resume where they are most relevant.

  • Pharmacovigilance
  • Drug Safety
  • Clinical Trial Management System (CTMS)
  • Clinical Research
  • Electronic Data Capture (EDC)
  • Good Clinical Practice (GCP)
  • EudraCT
  • Pharmacology
  • MedDRA
  • Clinical Development
  • Oncology
  • Standard Operating Procedure (SOP)
  • Oncology Clinical Research
  • Drug Development
  • CMC
  • Biotechnology
  • Adverse Event Reporting
  • Drug Discovery
  • Regulatory Affairs
  • Risk Assessment
  • Immunoassay
  • Chemistry
  • R&D
  • R&D Strategy
  • Hazard Analysis and Critical Control Points (HACCP)
  • Good Laboratory Practice (GLP)
  • Laboratory Medicine
  • Medicine
  • Medicine Clinical Research
  • Good Clinical Practice (GCP) Guidelines

Showcase Your Technical Skills

Pharmacovigilance specialists need to be proficient in a number of software programs and databases in order to effectively do their jobs. These might include the FDA’s Adverse Event Reporting System (FAERS), the European Medicines Agency’s (EMA) European Database of Suspected Adverse Drug Reactions (EudraVigilance), and the World Health Organization’s (WHO) Uppsala Monitoring Centre (UMC) database.

Additionally, pharmacovigilance specialists need to have a solid understanding of statistical analysis and data mining techniques. They should also be familiar with the various regulations governing pharmacovigilance, such as the FDA’s Good Pharmacovigilance Practices (GVP) guidelines.


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