Pharmacovigilance Manager

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.

Last updated on Jul 26, 2024