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MissionTasks and Responsibilities
Mainly:
* Operational support to clinical trial activities including but not limited to SAE management, reconciliation, unblinding activities as well as support in safety monitoring activities during development.
* Management of Aggregate Reports (DSUR) and other periodic reports required by regulators to ensure data completeness by data lock, including providing tables and listings for these reports.
* Revision of the synopsis, safety sections of protocols, Data Management Plan, Safety Topics of Interest, and accountability for the RSI of the study.
* Lead the creation of the Safety Reporting Plan.
* Active participation in internal and CRO clinical study team meetings.
* Operational support to non-interventional studies, market research, registries, including ICSR management, reconciliation, and safety monitoring activities.
* Post-marketing safety surveillance activities.
* Support to the Patient Safety Director and EUQPPV in fulfilling internal duties and responsibilities towards authorities.
* Contribute to the Pharmacovigilance Quality Management System and implement necessary procedures per legislation.
* Perform safety database tasks as applicable.
Education
Science Degree. Relevant post-graduate training in pharmacovigilance, clinical safety, or epidemiology is preferred.
Specific Knowledge
Experience with safety databases, GVPs, and relevant regulations.
Experience
At least 5 years of PV experience. Experience in a corporate safety department is preferred.
Values and Competencies
• Care: Listening, empathizing, valuing diversity, and supporting each other's success.
• Courage: Challenging the status quo, taking ownership, and learning from successes and failures.
• Innovation: Centering on patient and customer needs, creating novel solutions, and fostering entrepreneurial mindsets.
• Simplicity: Acting decisively, understanding reasons before acting, being agile, and maintaining simplicity.
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