Safety Scientist - Case Processing and Literature (London)
Responsible for supporting all operational functions within the Global Case Processing Department including, but not limited to, client interface and deliverables, Individual Case Safety Report (ICSR) case processing and reporting, global literature review, assisting with project start-up, database configuration request, database outputs request/review, and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.
Specific job duties:
- Assist with the writing of procedural documents such as Adverse Event Reporting Plans (AERPs)
- Supporting the preparation of SAE and pregnancy forms as needed
- Responsible for processing and evaluating (coding, narrative writing, seriousness, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post marketing experience according to the applicable SOPs and Project Specific Plans
- Responsible for the timely completion and reportability assessment of safety reports for distribution to Health Authorities, clients and client’s partners.
- Responsible for the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature
- Responsible for Quality Control of Case Processing and Literature Review deliverables
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data
- Participate in the submission activities to the Health Authorities as required
- Ensure the timely and accurate completion of case processing due diligence activities
- Ensure the timely and accurate completion of reconciliation activities
- Assist in the reconciliation of clinical and safety databases
- Supporting the protocol review of the safety section as needed
- Assist with the preparation and follow through to completion the Safety Database requests (case deactivation, Output Request, Change Control and User Access Request Forms as appropriate) for UBC PV management review and approval
- Provide and assist with appropriate documentation of non-compliance with regulatory requirements and / or applicable procedures in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required
- Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
- Alert PV management for any identification/escalation of issues
Desired Skills and Qualifications:
- Registered Nurse, Pharmacist, or other degree in a science or health-related field
- Comprehensive knowledge of global and local Pharmacovigilance Regulations and Guidelines for both pre and post marketing
- Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g. CRO) with case processing responsibilities
- PV processing experience should include drugs. Experience with safety surveillance of vaccines, biologics and medical devices a plus but not required.
- Proficient with case processing including use of coding dictionaries, case narratives preferably within Argus. Experience with other PV databases (e.g. ARISg) a plus, but not required.
- Experience in expedited reporting a plus, but not required
- Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, Excel)
- Good communication, interpersonal interaction, and organizational skills are essential
- Ability to manage multiple client projects simultaneously with good time management skills
- Fluent in English, additional language fluency a plus, but not require
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, understanding 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.
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