Junior PV Officer

About the role

Ergomed is recruiting a Junior PV Officer in Madrid for its pharmacovigilance business, PrimeVigilance. This is a mid-senior position requiring previous experience in pharmacovigilance case processing, supporting the project team and the ICSR management unit for clients.

Key responsibilities

• Process Individual Case Safety Reports (ICSRs) from all sources in line with regulations, PrimeVigilance procedures and client requirements and timelines
• Carry out ICSR follow-up and SAE/SUSAR management (unblinding, clinical trial reconciliation, protocol and Safety Management Plan review)
• Handle product quality complaints and interact with Quality Assurance and Medical Information
• Perform MedDRA and WHO coding, prepare database outputs and reports including data for monthly client reporting
• Mentor and train new and more junior employees, and support PV processes for both PrimeVigilance and clients
• Act as LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and as PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Required profile

• Healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated pharmacovigilance experience
• Fluent English, spoken and written
• Organization, planning and time management, delegation and teamwork skills

Required skills

• Advanced MS Office literacy
• MedDRA and WHO coding