Pharmacovigilance Intern at Harrow, Inc.

, , United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jul, 26

Salary

0.0

Posted On

01 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Drug safety, Adverse event processing, Regulatory compliance, Data entry, MedDRA coding, Narrative writing, Literature surveillance, Medical terminology, FDA regulations, ICH guidelines, Communication skills, Organizational skills, Microsoft Office Suite, Clinical research, Quality assurance

Industry

Pharmaceutical Manufacturing

Description

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us. Who is Harrow? Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of! Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including: An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE® A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVITM A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA® A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01 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%

Responsibilities

The Pharmacovigilance Intern will assist in the intake, documentation, and triage of adverse events, product quality complaints, and medical inquiries. They will also perform data entry, narrative writing, and support literature surveillance activities to ensure regulatory compliance.