Pharmacovigilance Case Specialist - QC & Compliance

ProductLife Group; Portugal; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A biotech consulting firm in Portugal seeks a Case Specialist to join their pharmacovigilance team. The role involves providing specialized support in case management, ensuring compliance with regulatory standards, and performing quality control on safety reports. Candidates should have a degree in pharmacy, a minimum of 3 years of pharmacovigilance experience, and proficiency in relevant databases. Strong communication and analytical skills are essential.

Qualifications

• Minimum 3 years of experience in pharmacovigilance, preferably in a service provider setting.
• Proven ability to meet deadlines and manage client communications.
• Strong understanding of pharmacovigilance principles and regulatory frameworks.

Responsabilités

• Perform QC for post-marketing cases.
• Analyze ICSR download inclusion/exclusion.
• Review and assess safety reports.
• Query and resolve case discrepancies.
• Ensure compliance with GVP, GCP, FDA, and other regulatory requirements.

Connaissances

Pharmacovigilance

Client communication

Deadline management

Analytical skills

Formation

Degree in Pharmacy

Outils

SafetyEasy database

Microsoft Office

Description du poste

A biotech consulting firm in Portugal seeks a Case Specialist to join their pharmacovigilance team. The role involves providing specialized support in case management, ensuring compliance with regulatory standards, and performing quality control on safety reports. Candidates should have a degree in pharmacy, a minimum of 3 years of pharmacovigilance experience, and proficiency in relevant databases. Strong communication and analytical skills are essential.