PHARMACOVIGILANCE ASSESSOR

Position Overview

Objective of the Role

Evaluate the safety and effectiveness of pharmaceutical products following their approval, throughout clinical studies, compassionate use initiatives, and compassionate prescription scenarios, particularly in the domains of onco-hematology, hematology, and nephrology.

Key Responsibilities

• Examine pharmacovigilance information from diverse sources
• Oversee pharmacovigilance signals and notifications
• Draft safety sections of assessment reports for various procedures
• Assess applications for modifications in marketing authorizations
• Supervise national pharmacovigilance inquiries
• Track pharmacovigilance reports for early access initiatives
• Remain updated on drug safety within pertinent medical areas

Candidate Profile

Educational Background

Doctor of Pharmacy / A minimum of 5-6 years in the medical, pharmaceutical, or scientific sector. A Master's degree or Postgraduate Diploma in Pharmacovigilance is preferred.

Professional Experience Required

Background in pharmacovigilance and/or clinical operations related to relevant product categories.

Essential Skills

• Capability to interpret pharmacovigilance data
• Strong organizational abilities
• Interpersonal skills and teamwork orientation
• Attention to detail, methodical approach, and synthesis capabilities
• Knowledge of regulatory frameworks
• Proficient in Microsoft Word, Access, Excel, and PowerPoint
• Competent level of English is necessary