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 RESPONSIBILITIES

• Support the Vigilance Manager in the performance of daily Vigilance dept. tasks
• Ensure adherence to regulatory requirements as well as internal/ clients' SOPs and relevant contractual agreements' obligations
• Collect, 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 environment
• Perform data entry of safety information in clients' Vigilance Database and other relevant data collection tools
• Perform ICSR data entry & submission to EudraVigilance via EVPM/ EVCTM modules
• Screen local and global literature for the identification of safety information
• Plan & author periodic reports, aggregate safety reports, and safety analyses (e.g., DSURs/ PSURs)
• Author Risk Management Plans (RMPs)
• Perform Signal Management activities
• Monitor National and European safety regulation and guidelines updates
• Submit initial/updated information on medicinal products to XEVMPD
• Act 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 data
• Build, review and maintain local medical information content (i.e. standard response letters, literature comparisons, slide decks).
• Support reconciliation activities both internally and with external stakeholders
• Support clients' Pharmacovigilance System Master File creation & maintenance
• Support the execution of the annual Vigilance Training plan to internal personnel & clients' employees
• Support audits/inspections' preparation and CAPA Plan development and implementation

REQUIREMENTS

• University Degree in Health Science's field (or Medical background) is required
• 1-2 years of relevant experience is required
• Previous working experience in ICSR handling is required
• Previous working experience in PSUR authoring is required
• Previous working experience in Signal Management is desired
• Solid working knowledge of National and European safety regulatory requirements and guidelines
• Excellent interpersonal, written and verbal communication skills in both English and Greek.
• Able to search, understand and summarize scientific literature
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Strong customer service-oriented approach
• Excellent computer skills (including word processing, spread sheet, and data base management applications)

WHAT WE OFFER

Creative 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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