Pharmcovigilance Case processing & Quality Product Complaint Specialist

ProPharma seeks a pharmacovigilance and quality specialist to support case processing and product complaint activities for a global life-sciences client in Scandinavia. The role involves adverse event review, regulatory coding, data management, and cross-functional collaboration on a hybrid basis in Malmö for at least six months.

Responsibilities

• Review adverse event reports and quality complaints; verify accurate database entry
• Perform case triage, MedDRA coding, and quality assurance checks as needed
• Assess seriousness, expectedness, and regulatory reporting requirements per EU GVP guidelines
• Ensure timely ICSR submission and product complaint documentation per internal procedures
• Monitor complaint timelines and collaborate with internal stakeholders

Requirements

• University degree in life-sciences discipline
• Demonstrated experience in pharmacovigilance case processing or QA product complaints
• Fluent in English; Swedish or Danish proficiency preferred
• Strong attention to detail and procedure compliance
• Excellent communication skills