Pharmacovigilance Document Specialist

4 giorni fa


Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Key Responsibilities
  • Aggregate Reporting: Aggregate and consolidate data for Periodic Safety Reports, Safety Strategy, and Core Benefit-Risk Documents for global products, working closely with cross-functional teams.
  • Regulatory Compliance: Ensure compliance with domestic and international regulatory safety reporting requirements, monitoring PSURs/PBRERs and DSURs submissions for global products.
  • Document Management: Develop and distribute high-quality pharmacovigilance documents, including aggregates report submission to Health Authorities where applicable.
  • Collaboration and Communication: Lead cross-functional working teams, manage related Health Authorities' assessments, and effectively communicate technical and scientific information in critical submission and internal PV documents.
Requirements
  • Experience: Minimum 1 year of experience in pharmacovigilance, with a focus on medical writing and regulatory safety reporting.
  • Education: Master's degree in science or a related field, with a preference for PhD holders.
  • Language: Fluent English language skills.
  • Technical Skills: Data analysis, procedures writing, and knowledge of domestic and international regulatory safety reporting requirements.
  • Soft Skills: Adaptability, communication, conflict management, negotiation, and quality orientation.
About Chiesi

Chiesi Group is a dynamic and growing company that invests in continuous training, learning, and development. We strive to promote and satisfy development needs, paying attention to the quality of our working environment and collective well-being.

We offer a flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and other people-care services to maintain a healthy work-life balance.



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