Senior Safety Scientist - Safety Writing
- Experience Level
- Experienced (non-manager)
This position is responsible for supporting all operational functions within the Global Case Processing unit including, but not limited to, safety report case processing and reporting, global and local literature review, assisting with project start-up, training, mentoring and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.
- Bachelor's Degree in a science or health-related field, pharmacy or nursing required.
- Minimum of 3 years of experience in a pharmaceutical company or a service provider (e.g., CRO) with case processing responsibilities.
- Good knowledge of global and local pharmacovigilance (PV) regulations and legislation, both pre- and post-marketing required.
- Case 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 writing and causality assessment preferably within Argus.
- Experience with other PV databases (e.g. ARISg) a plus, but not required.
- Experience in expedited reporting.
- Experience in global and local literature review a plus, but not required.
- Good communication, interpersonal interaction and organizational skills.
- Ability to manage multiple client projects simultaneously with good time management skills.
- Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, and Excel).
- Must be able to speak fluent English.
- Train and mentor new or junior personnel assigned to project teams.
Specific Job Duties:
- Ensures the role of workflow manager as assigned by UBC PV Management.
- Responsible for processing (i.e. narrative writing, seriousness, causality and expectedness assessment) and evaluating safety reports originating from clinical studies, literature and the post marketing experience for client specific products.
- Responsible for the timely completion 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 safety report, aggregate data, line listings.
- 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.
- Prepare 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.
- Assist, in conjunction with the Argus team and UBC PV management, in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts.
- Assist with the preparation and reviews of relevant project specific plans and procedures linked to case processing and literature activities.
- Assist with the preparation of training materials specific to Case Processing and Literature Review, participate and/or lead training sessions.
- Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
- Attends client operational Face to Face meetings and Investigator meetings as needed.
- Collaborate with UBC PV Management to update or design project process improvements
- Escalates to UBC PV Management when activities fall outside contracted tasks in SOW or applicable procedural documents.
- 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.
- Assist in client audits and regulatory inspections from a pharmacovigilance operations standpoint.
- Other duties as assigned by UBC PV Management.
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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