Purpose of the function

Roles and Responsibilities

• Review of study protocols and study oversight plans to ensure appropriate safety data collection and consistency in safety requirements across activities related to a similar product
• Develops and maintains AE/SAE Flow Plans
• Review of electronic case report form (e CRF)
• In conjunction with Data Management/Medical Affairs, actively participates in establishing the electronic data capture (e DC) strategy at the project and/or clinical activity level. Proactively identifies and manages risks as it relates to data capture and reporting. Establishes e DC standards for reporting to ensure quality and compliance in safety reporting
• In conjunction with Medical Safety and affiliates, reviews proposals for clinical solicited activities including Expanded Access Programmes, compassionate use, patient support programmes and market research to ensure appropriate methodology for the collection of AE information is outlined.
• Participates in the review of contracts with third parties engaged in supporting clinical activities (e.g. market research vendors) and also where the sponsor of the activity is not DS (i.e. Investigator Initiated Studies) to ensure roles and responsibilities are appropriately defined
• Support workflow monitoring of solicited cases to ensure that volumes and data capture is proceeding as expected
• May act as a back up to or be assigned as a Global Study Lead for specific protocols/products. In such assignment, represents PV Operations at multidisciplinary study meetings providing guidance, oversight of initiatives and trouble-shooting issues
• Contributes to TMF activities

• Perform oversight of safety data reconciliation from clinical activities
• Handles complex solicited ICSR queries and issues
• Develops and delivers training material related to clinical activity safety data management
• Supports process redesign activities, proactively identifying areas of potential improvement and process optimization and suggests potential solutions with a focus on compliance and consistency
• Reviews and provides input to SOPs, SOIs and guidance documents in accordance with regulatory requirements
• Maintenance of clinical activity tracking information, as applicable

• Identifies process deviations and participates in the generation of CAPA
• Prepares and reviews CAPA
• Participates as an SME in audits and inspections
• Escalates issues to experienced colleagues, the Senior Manager PV Operations and the PV Operations Lead
• Interacts with the global CSPV team and has interactions with DS affiliates, cross-functional departments and external partners

Education & Experience

• Bachelor’s degree at minimum required (Life Science, Pharmacology, Medicine) and minimum of 5 years’ or total of 7 years’ experience in PV; may also have an advanced degree Required
• Strong understanding of European and International PV regulations Required
• Experienced in multiple areas of PV operations, particularly interventional and non-interventional trials; technical experience in electronic data capture and safety reporting preferred Required
• Excellent computer skills Required
• Excellent knowledge of English Required

Skills and additional Requirements

• Works independently, identifying issues, recognizes functional impact, develops and implements solutions
• High attention to detail, ensuring high quality work is completed to expected timelines
• Highly reliable
• Positive attitude
• Very good communication skills, including cross-culturally