Pharmacovigilance Specialist (Case Processing)
B
BiomapasPharmaceutical / CRO
Croatia. Bulgaria. Romania. Ukraine. Serbia. Poland. Position is full-time remote/home-based in any European country and Turkey.Full-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Proficiency in both verbal and written local language and English
- Experience
- At least 1 year of experience in Safety and Pharmacovigilance
- Required Skills
- MS Office
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
- Knowledge of EU GVP modules
- Knowledge of applicable global safety regulations (e.g. ICH, FDA reporting requirements)
- Experience with Veeva Vault Safety system (beneficial)
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
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