Safety Scientist, Global Case Processing

Пълно описание

Unique Features:

• Leading provider of pharmaceutical services;
• One of the best in evidence-based research for both emerging and leading pharmaceutical companies;
• The first office in Bulgaria.


Responsibilities:

• 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 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;
• 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 of the Safety Database requests;
• Assist 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;
• Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint.


Requirements:

• A bachelor's Degree in a science or health-related field, pharmacy or nursing;
• Minimum of 1 year 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 is a plus but not required;
• Proficient with case processing including the use of coding dictionaries and case narrative writing, preferably within Argus
• Experience with other PV databases (e.g. ARISg)
• Experience in global and local literature review is a plus;
• 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.


What they offer:

• Competitive remuneration;
• Entirely remote work;
• Opportunities for development;


If you find our proposal interesting and want to receive more information, please, send your CV in English by applying online!

We thank all interested applicants, but we will only contact a shortlist of them! All applications are confidential.
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