Pharmacovigilance Specialist / Deputy QPPV

Key Responsibilities:

• Act as Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) for Ukraine and Moldova, with involvement in and understanding of all local PV activities and processes
• Maintain the local PV system in compliance with local legislation and global company standards
• Manage and oversee ICSRs, including cases related to clinical trials and medical devices
• Manage safety aggregate reports, including PBRERs, DSURs, A13 submissions, and other regulatory safety documentation
• Coordinate DHPCs and other safety communications
• Monitor safety information sources (medical literature, local regulatory authorities) and support local signal management activities
• Participate in internal audits and regulatory inspections
• Manage and oversee internal and external partners, including safety agreements and reconciliation activities
• Monitor changes in local PV and regulatory legislation
• Collaborate with regulatory authorities, direct market service providers, global teams, and external partners
• Support cross-functional internal projects and initiatives
• Conduct initial and refresher PV training sessions for internal and external stakeholders

Requirements:

• English level: Intermediate+ / Upper-Intermediate (confident understanding of written and spoken communication, participation in business discussions, and communication with international teams)
• 2+ years of experience in PV within a pharmaceutical company
• Strong knowledge of Ukrainian PV and regulatory requirements
• Experience interacting with regulatory authorities
• Strong sense of responsibility and self-organization
• Ability to work effectively in a dynamic environment and adapt quickly to change
• Fast learner with the ability to quickly absorb new information
• Strong attention to detail, deadline and accuracy
• Well-developed communication and cross-functional collaboration skills