Pharmacovigilance Intern

Harrow, Inc.
Hybrid

About The Position

The Pharmacovigilance Intern will support the Pharmacovigilance team with day-to-day activities in drug safety surveillance, adverse event (AE) processing, and regulatory compliance. This role provides hands-on exposure to pharmacovigilance processes, including intake and triage of incoming inquiries in compliance with regulatory requirements, management of Individual Case Safety Reports (ICSRs), safety database entry, and literature surveillance. The intern will collaborate with cross-functional teams, including Quality Assurance, Regulatory, Clinical, and Medical Affairs, to gain a well-rounded understanding of pharmacovigilance within the pharmaceutical industry.

Requirements

  • Currently pursuing or recently completed a Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Pharmacy, Life Sciences, Public Health or related field)
  • Strong interest in pharmacovigilance, drug safety, and pharmaceutical development
  • Excellent written and oral communication skills
  • Strong organizational skills and attention to detail
  • Ability to manage multiple tasks and meet deadlines in a fast-paced environment
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
  • Self-motivated with a proactive approach to learning and problem-solving
  • Ability to work both independently and collaboratively within a team setting

Nice To Haves

  • Basic understanding of pharmacovigilance concepts (e.g., adverse events, product quality complaints, case intake/processing) is a plus
  • Familiarity with medical terminology is preferred
  • Familiarity with FDA regulations and ICH guidelines is a plus
  • Prior internship or coursework experience in pharmacovigilance, quality assurance, clinical research, or healthcare is preferred but not required

Responsibilities

  • Assist in the intake, documentation, and triage of incoming inquiries, including adverse events (AEs), product quality complaints (PQCs), and medical inquiries, in accordance with internal procedures and regulatory requirements
  • Perform data entry, coding (e.g., MedDRA), and narrative writing within the safety database
  • Support follow-up activities to obtain missing or additional information from reporters or internal stakeholders
  • Aid in literature surveillance activities, including screening scientific publications for potential adverse events
  • Provide support in the preparation of safety reports for submission to regulatory authorities
  • Collaborate with cross-functional teams (e.g., Medical Affairs, Regulatory, Quality, Clinical) to support pharmacovigilance activities
  • Perform other duties and projects as assigned to support the Pharmacovigilance department
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