Pharmacovigilance Specialist – Case Processing

This is a fully remote position, open to applicants in Croatia, +5 more states.

📋 Description

• Supervise and coordinate the workflow of safety case reports to ensure efficient processing.

• Perform prioritization of safety case reports to determine urgency and necessary actions.

• Review, manage, and archive source documentation to comply with regulatory standards.

• Process safety case reports, which includes SDB data entry, narrative creation, seriousness evaluation, medical review, causality and expectedness assessments, and assessment of reporting obligations.

• Carry out follow-up tasks and handle inquiries related to safety case reports.

• Implement quality control measures on data entry and case processing to guarantee accuracy and compliance.

• Reconcile safety case reports to maintain consistency and completeness of information.

• Create line listings to summarize and report on safety case data.

• Liaise with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding operational execution, quality benchmarks, client relationships, company reputation, and additional project tasks.

⛳️ Requirements

• Bachelor's degree in a Life Science discipline.

• Minimum of 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) sector.

• Proficient in both verbal and written communication in the local language and English.

• Strong skills in MS Office applications.

• Experience with the Veeva Vault Safety system is advantageous.

• Familiarity with EU GVP modules and relevant global safety regulations, including ICH and FDA reporting requirements.

• CV must be submitted in English for further evaluation.

🏝️ Benefits

• Fully remote and flexible work arrangements.

• Opportunities for professional development and career advancement.

• Work within an international team and environment.