Senior Pharmacovigilance Associate

About the role

Ergomed is hiring a Senior Pharmacovigilance Associate in Cluj-Napoca to work in its ICSR management unit. The role covers processing Individual Case Safety Reports, following up cases and supporting the RA and PV network department, including acting as the local contact person for pharmacovigilance (LCPPV) for a specified country and as the person responsible for local screening (PRLS) for a designated language.

Key responsibilities

• Process Individual Case Safety Reports (ICSRs) from all sources in line with regulations, company procedures and client requirements and timelines
• Carry out ICSR follow-up and manage SAE/SUSAR cases (unblinding, clinical trial reconciliation, protocol and Safety Management Plan reviews)
• Handle clinical and partner data reconciliation
• Manage product quality complaints and interact with Quality Assurance and Medical Information
• Code reports using MedDRA and WHO coding, and prepare database outputs and reports for monthly client reporting
• Manage workflow and resources, and support PV processes for both the company and its clients
• Support the RA and PV network department as needed, including the LCPPV and PRLS roles, as agreed with the line manager

Required profile

• Graduate in life sciences, pharmacy, nursing or another healthcare-related field, or experience in pharmacovigilance
• At least 1 year of work experience in pharmacovigilance
• Advanced English (spoken and written)
• Strong organization skills, attention to detail and ability to multitask
• Time and issue management skills

Required skills

• MedDRA and WHO coding
• Advanced MS Office literacy