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 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;
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.
JobTiger is a Bulgarian online job board and licensed recruiting
company (License No.2547, 08.06.2018).
