Local Safety Senior Associate (1‑Year Fixed‑Term)
Amgen · Istanbul
Job description
About the role
Amgen is seeking a Local Safety Senior Associate to support Global Patient Safety activities in Turkey. The role involves handling adverse event reporting, ensuring regulatory compliance, and providing safety expertise to local business units.
Key responsibilities
- Capture, translate, route and follow up adverse event reports for inclusion in the Global Safety database.
- Assist with timely submission of reportable adverse events and distribution of periodic safety reports.
- Support dissemination and tracking of urgent safety communications, DHPCs and DILs.
- Maintain knowledge of local pharmacovigilance regulations and update SOPs accordingly.
- Provide safety training to customer‑facing employees and partners.
- Assist during audits, inspections and other regulatory interactions.
Required profile
- Master’s degree or bachelor’s degree with at least 2 years of relevant experience.
- Valid Pharmacovigilance Officer Training certificate issued by the Turkish Medicines and Medical Devices Agency (TİTCK).
- Good understanding of local data‑privacy requirements and ability to prioritize safety issues.
- 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.
- Knowledge of local pharmacovigilance legislation and company safety policies.
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Published 8 saat önce
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Amgen
Istanbul