Global Pharmacovigilance Documents Specialist
4 giorni fa
Key Responsibilities:
• Support the Coordinator in global planning for pharmacovigilance documents.
• Develop, consolidate, update, and distribute aggregates for global products with cross-functional teams.
• Ensure compliance monitoring for PSURs/PBRERs and DSURs submitted for global products/molecules under development.
• Lead cross-functional working teams and manage Health Authorities' assessments.
• Support Safety Physicians in writing relevant sections of documents for product renewals and provide necessary support in case of RSI.
• Collaborate cross-functionally for continuous improvement of standards and best practices for medical writing.
• Upload pharmacovigilance documents in the EDMS through appropriate workflows.
• Monitor aggregates inbox and HA websites for aggregate management purposes.
Requirements:
• Minimum 1 year of experience in pharmacovigilance, with medical writing experience preferred.
• Theoretical and practical knowledge of PSUR/PBRER, ACO, RMP, and DSURs.
• Master's degree in science, PhD, or similar preferred.
About Us:
Chiesi Group offers a dynamic, fast-growing, challenging, and friendly environment. We invest in continuous training, learning, and development, promoting quality of working environment and collective well-being.
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