Vigilance Officer

The position implements daily operations of the Vigilance Department, including the processes for collection, monitoring, processing, distribution and regulatory reporting of safety information, aggregate reporting and medical information queries for medicinal products, medical devices, cosmetics, and food supplements. Ensures timely and high-quality deliverables, as per clients’ contract terms, Standard Operating Procedures (SOPs) and applicable Vigilance regulatory requirements. MAIN RESPONSIBILITIESSupport the Vigilance Manager in the performance of daily Vigilance dept.

tasksEnsure adherence to regulatory requirements as well as internal/ clients’ SOPs and relevant contractual agreements’ obligationsCollect, assess, process, follow-up of incoming safety information from all sources relevant to Medicinal Products/Medical Devices/ Cosmetics/ Food Supplements both in pre- and post-marketing environmentPerform data entry of safety information in clients’ Vigilance Database and other relevant data collection toolsPerform ICSR data entry & submission to EudraVigilance via EVPM/ EVCTM modulesScreen local and global literature for the identification of safety informationPlan & author periodic reports, aggregate safety reports, and safety analyses (e. g.

, DSURs/ PSURs)Author Risk Management Plans (RMPs)Perform Signal Management activitiesMonitor National and European safety regulation and guidelines updates Submit initial/updated information on medicinal products to XEVMPDAct as a Medical Information Officer providing up to date, accurate and approved responses to medical inquiries from external customers including healthcare professionals and patients. Prepare responses to inquiries based on research in scientific literature Review of all Medical Information enquiries for the presence of safety dataBuild, review and maintain local medical information content (i. e. standard response letters, literature comparisons, slide decks).

Support reconciliation activities both internally and with external stakeholdersSupport clients’ Pharmacovigilance System Master File creation & maintenanceSupport the execution of the annual Vigilance Training plan to internal personnel & clients’ employeesSupport audits/inspections’ preparation and CAPA Plan development and implementation REQUIREMENTSUniversity Degree in Health Science’s field (or Medical background) is requiredMinimum 2 years of relevant experience is requiredPrevious working experience in ICSR handling is requiredPrevious working experience in PSUR authoring is requiredPrevious working experience in Signal Management is desiredSolid working knowledge of National and European safety regulatory requirements and guidelinesExcellent interpersonal, written and verbal communication skills in both English and Greek.

Able to search, understand and summarize scientific literatureAbility to manage multiple and varied tasks and prioritize workload with attention to detailStrong customer service-oriented approachExcellent computer skills (including word processing, spread sheet, and data base management applications) WHAT WE OFFERCreative Pharma & HR Services is offering a competitive remuneration package according to the Industry’s standards. Nonetheless, we are also proud at Creative Pharma & HR Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people’s potential and growth.

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