Jobs at Biomapas

Manages local pharmacovigilance compliance in Romania, acting as Local Safety Officer and Medical Information Specialist. Responsibilities include communicating with health authorities, processing safety information and product complaints, monitoring literature and regulations, maintaining quality standards, supporting audits and inspections, and handling medical information inquiries from patients and healthcare professionals.

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.