Jobs at Biomapas

Lead and oversee international pharmacovigilance operations, ensuring regulatory compliance and quality. Manage EU/UK QPPVs and PV teams, drive process harmonization, resource planning, inspection readiness, safety data oversight (PSURs, RMPs), PSMF governance, budget forecasting, and client project delivery. Act as subject-matter expert and may serve as EU/UK QPPV or project manager.

Lead development, implementation, and maintenance of the quality management system. Conduct GxP audits, manage vendor assessments, coordinate regulatory inspections, oversee corrective actions, support root-cause analysis, create and maintain QMS documentation, and deliver quality-related training to ensure compliance with GVP, GCP, ISO and other regulatory standards.

Manage local pharmacovigilance activities in Lithuania (and Malta): collect, process and communicate safety information; handle medical information requests; monitor literature; ensure regulatory compliance; liaise with health authorities; support inspections/audits; act as Local Safety Officer.

Conduct global and local literature screening, collect and communicate safety information, ensure compliance with local/regional pharmacovigilance quality systems, handle medical information enquiries, support inspections and monitor national PV regulations.

Serve as Local Safety Officer and Medical Information Specialist for Spain, ensuring compliance with local pharmacovigilance regulations. Collect, process, and communicate safety information, product quality complaints, and device incidents; monitor literature; liaise with health authorities; support audits and inspections; and handle medical information enquiries from patients and healthcare professionals.

The role involves maintaining pharmacovigilance compliance, communicating with health authorities, and handling safety information while ensuring quality standards are met.

The Pharmacovigilance Specialist ensures compliance with regulations, collects and communicates safety information, and maintains quality standards in pharmacovigilance activities.

The Pharmacovigilance Specialist ensures compliance with quality management systems, communicates with health authorities, and manages safety information in Italy.

The Junior QPPV Office Specialist supports pharmacovigilance compliance, database operations, and safety information processing while ensuring quality management systems and regulatory compliance.