Location: Zagreb, Croatia Reports to: Global Safety Manager based in Slovenia Temporary Employment: maternity leave replacement (until May 2027) Key Responsibilities: • Act as a contact point for the Agency, available 24 hours, • Act as a contact point for pharmacovigilance inspections in the Republic of Croatia. **Core Safety Responsibilities** + Collect, evaluate, and manage safety information in compliance with global regulatory requirements. + Assist in the preparation and review of safety reports and regulatory submissions. + Support ongoing safety surveillance activities, including signal detection and risk assessment. + Contribute to pharmacovigilance process improvement initiatives. + Collaborate with global and regional safety teams, as well as external stakeholders. **Collaborative Activities** + Participate in global, regional, and country safety meetings. + Provide input into Safety or cross-functional initiatives, as required, to share and develop best practices. **Local Safety Affiliate Activities (For local country)** + Maintain current knowledge of and compliance with local safety regulations. + Work with the Safety Country Lead to keep local affiliate safety requirements up to date in GPS SOPs and manuals, and reporting requirements. + Ensure that local safety activities are documented, filed, or archived in line with Amgen/GPS policies and procedures. + Assist in training on adverse event reporting obligations for local customer-facing staff, contractors, agents, business partners, or distributors. + Support the local Safety team during audits, inspections, and other PV interactions with local regulators. + Assist the Safety Country Lead and local teams to establish, review, and revise pharmacovigilance and/or contract agreements with partners, contractors/vendors, and distributors, as applicable. **Core Safety Affiliate Operational Responsibilities** + Timely and accurate capture, routing, translation, and follow-up of adverse events reported in the local country for inclusion in the Global Safety database. + Assist with the timely submission of all reportable adverse event reports. + Assist with the distribution of periodic safety reports for local and/or regional needs. + Support the dissemination of urgent safety communications, DHPCs, and DILs required by Amgen decisions or regulatory agency demands. + Assist in safety screening of local medical literature. + Facilitate the exchange of adverse event information with service providers, distributors, or business partners, in line with agreements or procedures. **Requirements** + Education: One of the following degrees is required: + Doctor of Medicine + Doctor of Dental Medicine + Master of Pharmacy + Master of Medical Biochemistry + Doctor of Veterinary Medicine + Minimum of 2 years of work experience in the field of pharmacovigilance. + Strong proficiency in English, both written and verbal + Residency in Croatia **Competencies** + Practical understanding of legislation relevant to local safety practices. + Competent computer literacy, including database use. + Knowledge of local data privacy requirements. + Strong understanding of relevant medical and safety terminology. + Ability to identify, prioritize, and escalate safety issues appropriately. + Problem-solving abilities and a proactive approach. + Confidence in handling core operational safety activities (once trained).