Job Summary

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.

Core 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

Qualifications & 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
• 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
• 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
• Prior internship or coursework experience in pharmacovigilance, quality assurance, clinical research, or healthcare is preferred but not required

Position Type

• Remote/Hybrid

Travel

• Minimal; up to 10%

Job Summary

The Regulatory Affairs Intern will support the Regulatory Affairs team with day-to-day activities across product lifecycle management, regulatory submissions, and compliance. This role provides hands-on exposure to FDA regulatory processes, including IND and NDA submissions, CMC documentation, labeling review, and agency correspondence.

The intern will collaborate with cross-functional teams, including R&D, Clinical, Quality Assurance, Manufacturing, and Medical Affairs, to gain a well-rounded understanding of regulatory affairs within the pharmaceutical industry.

Core Responsibilities

• Assist in the preparation, compilation, and review of regulatory submissions, including INDs, NDAs, supplements, amendments, and annual reports
• Support the maintenance and organization of regulatory files, submission tracking logs, and correspondence with the FDA
• Conduct research on FDA regulations, guidance documents, and industry standards relevant to ophthalmic and pharmaceutical products
• Support the review and assessment of change controls for potential regulatory impact
• Assist in monitoring the U.S. regulatory landscape for changes affecting ophthalmic products and summarize findings for the team
• Participate in cross-functional project team meetings and contribute to regulatory discussions
• Help maintain regulatory databases, tracking tools, and internal document management systems
• Support the development and improvement of regulatory SOPs, templates, and processes
• Perform other duties and projects as assigned to support the Regulatory Affairs department

Qualifications & Requirements

• Currently pursuing or recently completed a Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Regulatory Science, or related field)
• Strong interest in pharmaceutical regulatory affairs and drug development
• Familiarity with FDA regulations and ICH guidelines is a plus
• 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
• Prior internship or coursework experience in regulatory affairs, quality assurance, or pharmaceutical development is preferred but not required

Position Type

• Remote/Hybrid

Travel

• Minimal; up to 10%