Jobs at Biomapas

Manage performance management cycle and administer compensation and benefits. Maintain salary ranges, HRIS/payroll data consistency, prepare HR reports, support budgeting and forecasting, advise managers on compensation, and manage organizational structure and FTE records.

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.

Coordinate global pharmacovigilance audit and CAPA operations: maintain audit/CAPA trackers, enter and launch actions in Global QMS, collect supporting evidence, monitor overdue items, prepare PSMF/Module 7 documentation, issue audit notifications, distribute PV questionnaires, prepare status reports, and support SDEA processes while reporting to the Pharmacovigilance Manager.

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.

Lead pharmacovigilance activities including ICSR processing, SAE handling, signal detection, aggregate safety report preparation (DSUR, 6MLL), regulatory submissions, local PV coordination, literature monitoring, and audit/inspection support while ensuring compliance with global PV regulations and company SOPs.

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.