Corporate PV Operations Specialist

About the role

Fidia is expanding its Global Pharmacovigilance team in Egypt and seeks a Corporate PV Operations Specialist to manage safety activities for its diverse product portfolio, including medicines, medical devices, cosmetics and food supplements.

Key responsibilities

• Process all medical complaint cases from any source and ensure accurate entry into the safety database.
• Perform quality control, submit case reports to health authorities and partners within required timelines.
• Prepare line listings and summary tabulations for periodic safety reports (PSUR, DSUR, PBRER, Annual Safety Report).
• Conduct signal detection extractions using the BI module according to company strategy.
• Write and review SOPs and working instructions in line with national and international regulations.
• Support audit/inspection readiness and implement corrective and preventive actions.
• Reconcile safety data periodically with third parties, subsidiaries and internal departments.
• Assist with safety database administration, data migration projects and updates of XEVMPD and MedDRA dictionaries.

Required profile

• Degree in Pharmacy, Pharmacology, Pharmaceutical Chemistry, Biology, Biotechnologies or related scientific field.
• Minimum 3 years of experience in pharmacovigilance case processing and safety database management.
• Good knowledge of GVP, PV legislation and related guidelines.
• Fluent English and strong attention to detail.

Required skills

• Microsoft Office
• Safety Database Management
• Signal Detection using BI modules
• XEVMPD updates
• MedDRA dictionary handling

What we offer

• Permanent contract with Fidia Egypt.
• Annual gross salary between 359 000 EGP and 448 800 EGP.
• Access to unlimited training and coaching programs.