Junior Pharmacovigilance Associate _Croatia

Job Purpose and Responsibilities 1. Job Purpose Handle global safety activities for clients from clinical trial to post-marketing in compliance with SOPs, ICH, NMPA, FDA, EU and local regulations/standards/guidelines. 2. Responsibilities Monitoring regulatory authorities’ websites. Individual case safety reports management, including intake, triage, duplicate check, data processing, quality control, follow-up, submission and etc. Literature relevant tasks, including literature search, review, identify safety information, translation, quality control and etc. Reconciliation, including but not limited, cooperate with clinical data management to conduct SAE reconciliation, AE reconciliation and ADR reconciliation with clients or clients BP and etc. Support signal management. Draft/update/review safety management plan/safety data exchange agreement/PV agreement and etc. Participating in preparation of PSMFs and maintenance thereof. Documentation. Submit aggregate reports（PSUR, PBRER and etc.）/listings to regulatory authorities, partner companies, EC, investigators, and clients, as needed, to ensure compliance with regulatory and company timelines. Support PV database setup, configuration and gateway test. Participates in the meetings with clients or other functions and takes meeting minutes for safety part, if needed. Participation in medial inquiry services. Review SmPC and PIL as applicable. Preparation of documents and registration of local responsible persons. Support Regulatory Affair (RA) activities, if needed. Participation in the implementation of direct healthcare professional communication (DHPC). Preparing and participating in audits and inspections. Collaborate with department personnel to identify Drug Safety process needs and areas for improvement. Support training activities. Minimum Qualifications 1.Academic/Major Bachelor degree or above. Medicine, pharmacy, biology, nursing and equivalent major/working experience. 2.Professional Skills Basic familiarity with pharmaceutical /biotech / medical device industry and medicinal product development process. Knowledge of relevant guidelines, and regulations is preferred. Understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the pharmaceutical industry is highly desirable. Knowledge of MedDRA dictionary with relevance to adverse event coding is desirable. Experience with safety systems is preferred. 3.Other Proficiency Basic Microsoft Word, PowerPoint, Excel. Fluent English reading and writing and speaking. May require some domestic and/or international travel.