Drug Safety Associate II - PSUR Report Authoring and Review

As a PSUR Specialist, your primary responsibility will be to author and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities. You will play a crucial role in ensuring the accuracy, completeness, and regulatory compliance of all PSURs. Additionally, you will be tasked with performing literature searches to gather relevant data for PSUR preparation and validating the information obtained to ensure accuracy. Your role will involve extracting and validating data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). You will also be responsible for generating Line Listings (LL) from the safety database for inclusion in PSURs. Effective process management is key, as you will need to manage and reconcile relevant process trackers to ensure all activities are documented and on schedule. Providing reliable support for high-priority ad-hoc activities related to PSUR preparation will also be part of your daily tasks. Client interaction is an important aspect of this role, as you will communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies. It will be your responsibility to ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines. Furthermore, you will serve as a subject matter expert (SME) for PSUR preparation and review, providing training and mentoring to team members on PSUR-related processes and regulatory requirements. To excel in this role, you should hold a Bachelor's degree in a relevant scientific or medical field, with an advanced degree being preferred. Previous experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review, is essential. Knowledge of regulatory requirements for PSURs/PBRERs, strong analytical and problem-solving skills, excellent written and verbal communication skills, proficiency in safety databases and data extraction/validation processes, as well as strong organizational skills are key qualifications needed for this position. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert support will be critical for success in this role.,