Job Description

Pharmacovigilance Manager

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 Vice president of regulatory, Pharmacovigilance Manager plays a crucial role in ensuring the safety, quality, and accuracy of Harrow’s Approved Drug products. Some of the key functions include the operational and surveillance pharmacovigilance activities including but not limited to collection of adverse events from various sources, assessment and reporting of individual case safety reports (ICSRs), signal detection and compilation of aggregated safety reports. You will also lead continuous improvement efforts and maintain Pharmacovigilance activities with both External and internal Parties.

Essential Responsibilities

• Recording and reporting adverse reactions received from healthcare professionals, drug company representatives and patients
• Flagging up early warning signs of adverse effects of drugs
• Setting up and reviewing processes and training for incoming medical inquires (AEs, PQCs, Medical information requests )
• Data entry, or supervision of this work and contributing to research.
• Ensuring the rapid and timely processing and managing of new and follow-up reports of adverse events (AEs) and side effects, as well as serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs);
• Processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs), and as required by Regulatory Authority for reporting adverse events;
• Contacting those who reported the AEs and side effects to obtain complete information for analysis; Conducting in-depth interviews with patients and healthcare professionals when required
• Ensuring that assessments are carried out according to AE, SAE and SUSAR criteria and forwarding eventual AEs/SAEs and SUSARs to the head office;
• Contributing to keep local processes, procedures and systems up to date and assisting with, and participating in, audits and inspections when these arise.
• Support pharmacovigilance operations as required.

Qualifications

• Pharm-D, MD and RPN or educational equivalent.
• Around 5 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
• Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
• 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.

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