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Pharmacovigilance Specialist (Case Processing)

7 hours, 11 minutes ago
Bulgaria, Croatia, Hungary, Poland, Romania
Full-time
Junior
Operations Specialist
Quality Assurance and Testing
Apply Now
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001
View All Jobs 9

Description

  • Oversee and manage the workflow of safety case reports to ensure efficient processing.
  • Perform triage on safety case reports to determine priority and required 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, 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.
  • Communicate operational risks, quality issues, client relationship concerns, and reputational matters to the Pharmacovigilance Team Leader and Manager.
  • Handle ad hoc project tasks and requirements as needed.

Requirements

  • University degree in a Life Science field.
  • At least 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or 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, such as ICH and FDA reporting requirements.
  • CV must be provided in English for further assessment.
  • Ability to work full-time remotely from any EU country.

Interested in this position?

Apply directly on the company website

Apply Now

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