Safety Scientist, Global Case Processing - Bulgaria

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 and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.

Requirements:

• 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.
• Experience in expedited reporting a plus, but not required.
• 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.

Specific Job Duties:

• Responsible for processing and evaluating (i.e. narrative writing, seriousness, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post marketing experience for client products.
• Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and clients 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 reports, aggregate data, line listings.
• Ensure the timely and accurate completion of case processing due diligence activities.
• Ensure the timely and accurate completion of PV 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 of relevant project specific plans and procedures and other plans linked to case processing and literature activities as required and assigned by UBC PV Management.
• Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
• Escalates to UBC PV Management when activities fall outside contracted tasks in Scope of Work (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.
• Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint.
• Other duties as assigned by UBC PV Management.

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