Local Safety Senior Associate (1 Year Fixed Contract)

About the role

Support Global Patient Safety activities in Turkey by managing local safety operations, reporting adverse events, and ensuring compliance with regulations and Amgen policies.

Key responsibilities

• Capture, translate, and route adverse event reports for inclusion in the Global Safety database.
• Submit reportable adverse events and distribute periodic safety reports to meet local and regional requirements.
• Disseminate urgent safety communications such as DHPCs and DILs and track risk‑minimization measures.
• Maintain up‑to‑date knowledge of Turkish pharmacovigilance regulations and reflect changes in SOPs.
• Document and archive local safety activities according to Amgen and GPS policies.
• Provide training on adverse event reporting to internal and external stakeholders.
• Assist during audits, inspections, and interactions with regulatory authorities.
• Support resolution of safety issues, CAPAs, and quality assurance activities.

Required profile

• Master’s degree or bachelor’s degree with 2 years relevant experience.
• Valid Pharmacovigilance Officer Training certificate issued by the Turkish Medicines and Medical Devices Agency (TİTCK).
• Knowledge of local data‑privacy requirements and ability to prioritize safety issues.
• Problem‑solving ability and confidence in handling core operational safety tasks after training.

Required skills

• Computer literacy and competent use of safety databases and systems.
• Understanding of pharmacovigilance terminology and processes.
• Familiarity with adverse event reporting and regulatory compliance.