Safety Scientist, Global Case Processing Specialist
5 days ago
We are seeking a highly skilled Safety Scientist to join our Global Case Processing team at United BioSource. As a key member of our team, you will be responsible for supporting all operational functions within the Global Case Processing unit, including safety report case processing and reporting, global and local literature review, and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.
Key Responsibilities- Process and evaluate safety reports originating from clinical studies, literature, and post-marketing experience for client products.
- Timely completion of safety reports for distribution to Health Authorities, clients, and client's partners.
- 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 reports, aggregate data, line listings.
- 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.
- Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g. CRO) with case processing responsibilities.
- Bachelor's Degree in Biology or Pharmacy is required.
- 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 and case narratives writing, preferably within Argus.
- Experience with other PV databases (e.g. ARISg) 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).
As a Safety Scientist at United BioSource, you will have the opportunity to work with a talented team of professionals in a dynamic and fast-paced environment. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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