Responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, Individual Case Safety Report (ICSR) case processing, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.
Specific Job Duties:
Writing of procedural documents such as Adverse Event Reporting Plans (AERPs).
Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness and causality assessment.
Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings.
Assist in the reconciliation of clinical and safety databases.
Monitor compliance and ensure appropriate documentation (metrics, deviations).
Assist in evaluation and validation of systems to support safety e.g. supporting the development teams. in safety database configuration and EDC specifications.
Performing global and local literature review.
Project oversight and identification of issues. Escalation.
Registered Nurse, Pharmacist, or other Life - Science degree.
Comprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketing.
Experience in pre and post marketing Pharmacovigilance.
Experience in literature review.
Experience in case processing and PV regulatory reporting activities.
Experience in data entry in ICH E2B compliant database.
Knowledge of database management a plus.
Fluent in English, additional language fluency a plus, but not required.
Internal Number: REQ20012771
About United Biosource Corporation
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management.Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.By combining insight from data, understandi...ng patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.