Safety Scientist - Safety Writing
- Experience Level
- Experienced (non-manager)
Responsible for supporting all operational functions within the Global Safety Writing Team including, but not limited to, client interface and deliverables, assisting with project start-up, database outputs request/review, and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.
As part of the safety writing group, the safety writer leads the preparation of safety reports in constant interaction with the other teams of the Pharmacovigilance department of UBC.
Specific Job Duties:
- Participate in client safety signal management process
- Collect, review and quality control of safety data
- Assist with the preparation of safety assessments strategy.
- Prepare, review and quality control of periodic safety reports and other safety reports
- Ensures the quality and timely completion of the assigned sections of safety reports
- Maintain quality control documentations up to date
- Assist with the preparation of periodic safety preparation plans (PSRPs)
- Ensure all processes as described are operational
- Liaise with both internal and external vendors (clients, contractors)
- Assist in evaluation and validation of systems to support safety
- Assist in audits preparations
- 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
- Participate in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
- Alert PV management for any identification/escalation of issues.
- Pharmacist, Master’s degree or beyond (PhD) 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 experience in medical writing preferably in periodic aggregated reports or signal assessment reports
- Experience in preparation or Risk Evaluation and Mitigation Strategy (REMS) and KAB surveys
- Experience in screening of scientific literature is preferred
- PV experience should include drugs. Experience with safety surveillance of vaccines, biologics and medical devices a plus but not required.
- Experience with case processing including use of coding dictionaries, case narratives or expedited reporting is a plus.
- 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 required
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.
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