• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. • As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations). • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.). • Mentoring and training of new and more junior employees within the department, including procedure optimization and development.

• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations • Performing ICSR follow up SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) • Reconciliation (clinical, partners) • Personal data protection • Product Quality Complaint handling and interaction with Quality Assurance • Medical Information interaction • MedDRA and WHO coding • Database Outputs and Reports (including data for monthly reporting to clients) • Workflow & resource management • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients

• Providing support to other activities undertaken by the project team on behalf of the client and the company • Performing activities in the scope of ICSR management unit within agreed extent and timeframe • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines • Performing ICSR follow up SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) • Reconciliation (clinical, partners) • Personal data protection • Product Quality Complaint handling and interaction with Quality Assurance • Medical Information interaction • MedDRA and WHO coding • Database Outputs and Reports (including data for monthly reporting to clients) • Workflow & resource management • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients • More senior colleague may perform tasks assigned as per SOP to more junior position • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. • As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.) • Mentoring and training of new and more junior employees within the department, including procedure optimization and development