Jobs at Biomapas

Supports global and local pharmacovigilance systems, ensuring regulatory compliance across pre- and post-authorization activities. Manages PV projects, SOP updates, KPI reporting, case processing, safety reports, risk management plans, customer communications, audits, inspections, and health authority interactions. May serve as EU QPPV or deputy QPPV and contribute to forecasting and budget planning.

Leads global Central Pharmacovigilance Services, overseeing case processing, literature surveillance, signal detection, benefit-risk management, aggregate reporting, compliance, quality, and operational excellence. Builds scalable delivery hubs and outsourcing models, drives automation and AI adoption, manages KPIs and financial performance, supports audits and inspections, and partners with clients and cross-functional teams. Develops the leadership organization, succession planning, and global workforce capabilities while ensuring compliance with EU, FDA, ICH, and other pharmacovigilance regulations.

Responsible for local pharmacovigilance activities across the DACH region, including safety information processing, regulatory compliance, health authority and client communication, literature monitoring, audits and inspections, SOP development, medical information request handling, and PV training. The role serves as a local safety contact and supports quality standards for regional pharmacovigilance operations.

Manages clinical study start-up activities in Greece at country and site levels, including regulatory and ethics submissions through CTIS, authority communications, local document adaptation, essential document packages, site contracts, translations, database updates, and TMF filing. Advises study teams on local regulations and import/export requirements while coordinating status updates with sites, clients, vendors, and project teams.

Supports the quality management system through document control, training administration, quality metrics, audit coordination, CAPA management, investigations, root-cause analysis, risk assessments, corrective actions, and effectiveness checks. The role assists with internal audits, customer audits, and regulatory inspections while monitoring compliance and collaborating with international teams and clients.

Performs foundational pharmacovigilance activities under supervision, including case intake, triage, data entry, coding, follow-up, quality control preparation, literature monitoring, documentation, and audit support. Assists with safety database administration and prepares data for aggregate safety reports, risk management plans, and risk minimization activities. The role is remote in Germany and requires fluent English and German, strong organizational skills, attention to detail, and a life sciences education.

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.

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.