Local Safety Senior Associate – 1 Year Fixed-Term
amgen · Turkiye - Istanbul
Job description
About the role
Support the effective operation of Global Patient Safety activities in Turkey by conducting core local safety activities in line with legislation, Amgen policies and assigned responsibilities.
Key responsibilities
- Capture, route, translate and follow up adverse event reports for inclusion in the Global Safety database.
- Submit reportable adverse event reports and distribute periodic safety reports for local or regional requirements.
- Disseminate and track urgent safety communications, including DHPCs and DILs, and risk‑minimisation measures.
- Maintain knowledge of local pharmacovigilance regulations and ensure SOPs reflect current requirements.
- Assist with training of customer‑facing employees and other stakeholders on adverse event reporting obligations.
- Support audits, inspections and interactions with local regulatory authorities, maintaining inspection readiness.
Required profile
- Master’s degree or bachelor’s degree with at least 2 years of directly related experience.
- Valid Pharmacovigilance Officer Training certificate issued by the Turkish Medicines and Medical Devices Agency (TİTCK).
- Good working knowledge of company policies, procedures and relevant legislation.
- Problem‑solving ability and confidence in handling core operational safety activities after training.
Required skills
- Computer literacy with competent use of databases and safety systems.
- Understanding of medical and safety terminology.
- Knowledge of local data‑privacy requirements.
- Ability to identify, prioritize and escalate safety issues.
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Published 1 day ago
Expires 1 month from now
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amgen
Turkiye - Istanbul
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