CEE, Regulatory Affairs Specialist and Pharmacovigilance Officer

Location: Podgorica, Montenegro

Company

hirify.global provides consulting and operational expertise across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Prepare regulatory applications, supporting documentation, variations, renewals, notifications, amendments, and product recall materials.
• Communicate and negotiate with competent authorities and support clients on pricing, reimbursement, marketing materials, and local regulatory requirements.
• Monitor local and EU regulatory and pharmacovigilance legislation, authority updates, and relevant medical and scientific literature.
• Collect, assess, database, follow up, file, and report Individual Case Safety Reports and other safety information.
• Prepare and review PSURs, Addenda to Clinical Overview, Risk Management Plans, SOPs, service agreements, and safety data exchange agreements.
• Support audits, inspections, training, CAPA activities, compliance monitoring, signal management, and maintenance of the Pharmacovigilance System Master File.

Requirements

• Bachelor’s degree or higher in medicine, pharmacy, dental medicine, or medical biochemistry.
• Advanced theoretical and practical knowledge of local legislation in the countries where Clinres Farmacija operates.
• Experience with European and national regulatory submissions and interactions with regulatory agencies.
• Experience leading successful sub-projects and supporting client and stakeholder relationships.
• High computer literacy, strong organization, prioritization, multitasking, analytical, communication, and knowledge-sharing skills.
• Intermediate to advanced English, both verbal and written, is required.

Culture & Benefits

• Remote working is supported, with hybrid collaboration encouraged for new hires within a reasonably short commute of an office, as agreed with the manager.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, innovation, and entrepreneurial thinking.
• Applications are personally reviewed by the recruitment team without AI screening tools.
• Applicants receive an outcome regarding their application.