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. JobTiger is a Bulgarian online job board and licensed recruiting company (License No.2547, 08.06.2018).
JobTiger Recruitment е част от бизнес групата на JobTiger, като дейността му е фокусирана върху подбор на персонал.
Основната задача, която сме си поставили е да добавим стойност към бизнеса на нашите клиенти и към професионалното развитие на хората, които ни се доверяват да намерим най-подходящото работно място за тях. Успехът ни се дължи на индивидуалния подход, който използваме, в комбинация с изключително богата база данни и дългогодишни взаимоотношения, които сме изградили не само с клиентите си, но и с кандидатите.
Избирането на най-подходящата позиция за всеки кандидат е това, което ни мотивира да вършим работата си по най-добрия начин. Ентусиазмът в работата, гъвкавостта и бързата реакция към нуждите на всеки бизнес, са ключът за добрите резултати и успеха на нашия екип.
Това, което продължава да ни мотивира е стремежът към дългогодишни и успешни взаимоотношения както с компаниите-работодатели, така и със специалистите, които ни се доверяват всеки ден, за да извървим заедно пътя до успешното ново работно място.
Подборът се извършва от JobTiger, удостоверение No. 2547, 08.06.2018. JobTiger Recruitment, part of JobTiger Ltd., is focused on recruitment services and the main goal we have set is to add value to the business of our clients and to the professional development of all the people who trust us to find them the best workplace.
Our success is due to the individual approach we use in our communication along with our candidate’s database and the long-standing relationship we have developed not only with our clients, but also with the professionals we work with.
Choosing the right people’s workplace and position is what motivates us to do our job in the best possible way. The enthusiasm we put in our work, being agile and responsive to the needs of the business are the key factors to our success.
What motivates us more and more every day is the strive to build long and successful relationships with our clients and the candidates who trust us to build the path for a better workplace together. JobTiger is a Bulgarian online job board and licensed recruiting company (License No.2547, 08.06.2018).