The role of drug safety & pharmacovigilance

Drug safety teams collect, review, and follow up on reports of adverse events. They organize safety information so that qualified reviewers can assess cases and determine the appropriate next steps.

The work supports ongoing evaluation of a medicine’s safety profile and clear communication across research teams, healthcare professionals, and regulatory authorities.

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What the work involves

  • Collecting and documenting adverse event information
  • Reviewing safety reports for completeness and requesting follow-up
  • Entering and maintaining cases in safety databases
  • Supporting case narratives and tracking reporting timelines
  • Reconciling safety information across study records and systems

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Roles within this pathway

Titles and responsibilities vary by employer.

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  • Drug Safety Associate: Supports adverse event case processing, documentation, and follow-up.
  • Pharmacovigilance Associate / Specialist: Performs assigned safety activities, including case review, quality checks, and reporting support.
  • Safety Operations Coordinator: Tracks safety workflows, outstanding information, and team deliverables.
  • Safety Scientist: Evaluates safety information and contributes to identifying and assessing potential safety signals. These positions generally require additional scientific expertise and relevant experience.

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A pathway for diverse backgrounds

Drug safety draws on knowledge developed across pharmacy, nursing, medicine, life sciences, and health information. Experience reviewing clinical information, maintaining accurate records, and communicating clearly provides a relevant foundation for supporting safety activities.

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Accelerate your path into clinical research

Clintern Ascend combines industry training with a remote internship at a clinical research organization (CRO) partner. Gain experience with research workflows and study documentation while developing your understanding of how safety information moves through clinical trials, without taking time off work or school.

Dedicated résumé, interview, and career positioning support helps you communicate your experience to employers and pursue your next step with confidence. Specialized pharmacovigilance positions may also require training in safety databases and case processing.

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Industry Perspectives

Hear why industry executives recommend Clintern Ascend and Clintern CRA Global, and explore their perspectives on clinical research and career preparation.
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Shelly Ikeme

Global Head, HEMA CSS

Johnson & Johnson

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Nina Clarke-Walker

Director of Clinical Operations

Syneos Health

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