Senior Executive - Case Processing (CT Cases)

Responsibilities:

• Collects, records and checks for minimal requirements Serious Adverse Event (SAE) arisen during clinical investigations and during clinical trial
• Manages the generation of queries/questions in case of need of further information to complete or to understand the AE/SAE and manages the follow-up for ensuring efficient control and information flow
• Performs the AE/SAE reporting to the Sponsor, guaranteeing smooth and efficient information flow
• Prepares the case narratives, CIOMS I Forms, SAE Forms and all other applicable forms in order to perform safety reporting
• Manages the Safety Database
• Can act as first of contact for the Sponsor for safety matter
• Can act as back up of the safety contact for the Sponsor for safety matter
• Can act as first point of escalation for the Sponsor for safety matter • Performs the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR), arisen during clinical trials, to Competent Authorities (CAs), Ethics Committees (ECs) and other recipients ensuring compliance with applicable regulations and appropriate handling
• Manages the unblinding information
• Performs the reporting through EudraVigilance via EVWEB, if qualified
• Performs the periodic reporting to CAs, ECs and other recipients of safety documentation, ensuring compliance with applicable regulations and appropriate handling
• Performs the safety reporting of reportable safety issues (SAE) arisen during clinical studies with medical devices to CAs, ECs and other recipients, ensuring compliance with applicable regulations and appropriate handling
• Ensures tracking and documentation of the AE/SAE related correspondence creating set of information for future
• Supervises and Collects, records and manages the safety issues arising during the post marketing phase
• Manages the communication and reporting to the Clients of safety issues arising during the post marketing phase
• Performs the reporting to the CAs, applicable ECs and other recipients of safety issues arising during the post marketing phase
• Keeps herself/himself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects she/he will be assigned
• Prepares and reviews Safety Plans and AE/SAE Reconciliation Plans 4 Participates, for the Safety section, to the system audit, qualification audit and project audit
• Participates to the BID defence meeting
• Revises the Safety section during the protocol writing
• Writes the SOPs and Working Instructions in order to implement safety policy

Job requirements:

• University Degree in scientific, medical or paramedical disciplines
• At least six (6) years of Safety experience
• Excellent understanding of safety regulations in EU Member States (e.g. ICH, CT3, MDD, AIMDD, MEDDEVs) and implementation in national laws
• Ability to research safety requirements in International and National Regulation
• Fluent in English
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
• Willingness to travel
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