Sr Associate Global Safety

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).