PHARMACOVIGILANCE ASSESSOR
Il y a 2 mois
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
