Job Description

Drug Safety Associate

Ledgewood NJ

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 U.S. ophthalmic-focused pharmaceutical company. The Company was founded and continues operating based on the highest corporate values. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to and affordability of our 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.

At Harrow, we foster our individual and collective entrepreneurial and creative spirits. We focus on pursuing opportunities for drug candidates in underserved markets. We are data-driven and use our access to real-world clinical experience to lower the investment risks of our work. We concentrate on the commercial appeal of high-value assets, and our objective is to seek to make paradigm-shifting medicines available to patients as soon as possible. Our approach to finding high-value opportunities and balancing risk with real-world experience can deliver exceptional value for all our stakeholders.

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• IHEEZO:
• A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and TOBRADEX® ST;
• TRIESENCE®:
• A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO®, NEVANAC®, and VERKAZIA®;
• ImprimisRx is the nation’s leading ophthalmology-focused compound pharmacy, including an FDA-registered and FDA-inspected 503B outsourcing facility and a 50-state mail-order pharmacy. The division of Harrow serves as an innovation hub and plays a vital role in Harrow’s mission to help patients maintain their gift of sight.

Job Summary

Under the general guidance of the Associate Director, QA and Compliance, Drug Safety Associate plays a crucial role in ensuring the safety, quality, and accuracy of Approved Drug products. Some of the key functions include timely reporting to the FDA, managing Adverse Drug Reactions (ADRs) and strategic thinking skills. Lead continuous improvement efforts and maintain Pharmacovigilance activities. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information, coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. This role also effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors.

Essential Responsibilities

• Reviewing and evaluating incoming inquires (Product Quality complaints, Medical information requests and adverse event reports (AERs)) to determine if they meet regulatory reporting requirements and triage them accordingly
• Entering and maintaining incoming inquires and information in databases
• Narrative writing
• Communicating with healthcare professionals and other stakeholders to gather additional information about adverse events
• Assisting in the preparation of safety reports to be submitted to regulatory agencies
• Monitoring safety literature to stay current on the latest safety information related to the company's products
• Collaborating with other departments such as clinical research, regulatory affairs, Quality and pharmacovigilance to ensure compliance with safety regulations and guidelines
• Participating in the development and implementation of safety policies and procedures
• Reviewing and assessing the safety profile of new and existing products
• Participating in the development and execution of risk management plans
• Communicating with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues
• Support pharmacovigilance operations as required.

Qualifications

• Life Sciences or similar background or educational equivalent.
• Around 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
• Excellent written and verbal skills in English
• In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
• Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections
• Demonstrate ability to work independently as well as within teams
• Strong organizational and project management skills
• Demonstrate confidence, professionalism and credibility whilst interacting with customer and third parties
• Demonstrate an understanding of compliance and of quality management systems

Position Type and Expected Hours of Work

This is a full-time position in Ledgewood, NJ, with regular operations occurring between M-F between the hours of 9am-5pm. Working hours may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands.

Travel

Occasional travel up to 10% is expected for this position. Must be able to travel independently as an Harrow Eye, LLC representative.

Job Tags

Similar Jobs