Pharmacovigilance Specialist

About the role

EVA Pharma, a pharmaceutical company dedicated to improving health and well-being, is looking for a Pharmacovigilance Specialist to join its team in Giza. The role focuses on handling safety reporting and data submitted to the Egyptian Drug Authority.

Key responsibilities

• Collect, assess and process Individual Case Safety Reports (ICSRs) from various sources in line with applicable pharmacovigilance regulations.
• Ensure the quality, accuracy and completeness of pharmacovigilance data submitted to the Egyptian Drug Authority (EDA).
• Respond in a timely and complete manner to EDA requests for additional information needed for benefit-risk evaluation of pharmaceutical products.
• Provide the EDA with any other information supporting the ongoing benefit-risk evaluation of products.
• Collaborate with internal teams and external stakeholders to support pharmacovigilance activities and comply with SOPs and regulatory requirements.

Required profile

• Bachelor's degree in Pharmacy.
• 0-2 years of experience in pharmacovigilance or a related drug safety role.
• Good command of written and spoken English, with strong communication and documentation skills.

Required skills

• Knowledge of pharmacovigilance principles and ICSR processing.
• Understanding of applicable regulatory requirements.
• Strong analytical skills and attention to detail when handling safety data.