The Pharmacovigilance Specialist manages safety case report processing, ensuring compliance with regulations, conducting quality checks, and supporting team communication regarding operational risks.
The Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a focus on safety case reporting, processing of safety case report data, and literature screening activities. The role involves communication with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding potential risks related to operational delivery, quality standards, client relationships, and the company's reputation, as well as addressing ad hoc project tasks and requirements.
CV must be in English language for further assessment.
Position is full-time remote/home-based in any EU country.
Responsibilities:
- Oversee and manage the workflow of safety case reports, ensuring efficient processing
- Perform triage on safety case reports to assess priority and necessary actions
- Review, manage, and file source documentation in compliance with regulatory requirements
- Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluation
- Conduct follow-up activities and manage queries related to safety case reports
- Execute quality control checks on data entry and case processing to ensure accuracy and compliance
- Reconcile safety case reports to ensure consistency and completeness of data
- Prepare line listings to summarize and report on safety case data
Requirements
- University degree in Life Science field
- At least 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry
- Proficiency in both verbal and written local language and English
- Strong expertise with MS Office
- Beneficial experience with Veeva Vault Safety system
- Knowledge of EU GVP modules and applicable global safety regulations (e.g. ICH, FDA reporting requirements)
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on monthly case numbers
Top Skills
MS Office
Veeva Vault Safety
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