Turkish Local Safety Senior Associate – Pharmacovigilance

Amgen SA; Fatih; Sur place; TRY 150 000 - 230 000; Plein temps

Résumé du poste

Amgen Türkiye is seeking a LOCAL SAFETY OFFICER, SENIOR ASSOCIATE on a 1 year fixed contract to support Global Patient Safety activities in Türkiye. You will collect, process and submit safety reports, maintain compliance, and work with the Safety Country Lead to strengthen local pharmacovigilance.

The role involves training staff, assisting with audits and inspections, handling adverse event reporting, risk minimization, and contributing to safety initiatives across the local market.

Qualifications

• Master’s degree or bachelor’s degree with 2 years of directly related experience.
• Good working knowledge of policies, procedures, and systems; practical understanding of local safety legislation.
• Computer literacy, including databases and safety systems; knowledge of medical and safety terminology.
• Knowledge of local data privacy requirements and ability to identify and address safety issues.
• Problem-solving ability and confidence in core operational safety activities after training.
• Valid certificate of Pharmacovigilance Officer Training issued by the Turkish Medicines and Medical Devices Agency (TİTCK)

Responsabilités

• Timely capture and route adverse event reports in Türkiye for GPS database.
• Assist with submission of reportable adverse events and distribution of safety reports.
• Support dissemination of urgent safety communications (DHPCs, DILs) and risk minimization.
• Maintain knowledge of local pharmacovigilance regulations and update GPS SOPs.
• Ensure local safety activities are documented and archived per policies.
• Assist training of staff on adverse event reporting obligations.
• Support audits, inspections, and pharmacovigilance interactions with authorities.
• Contribute to CAPAs and quality assurance for local operations.
• Assist in establishing pharmacovigilance agreements with partners and vendors.
• Facilitate adverse event information exchange with service providers; screen literature.
• Review local study protocols to ensure safety monitoring and data collection.
• Develop product knowledge and keep updated on risk management plans.
• Escalate safety issues and contribute to medical discussions and training as needed.
• Support risk minimization activities and share stakeholder feedback.
• Participate in safety meetings and cross-functional initiatives.
• Perform other duties as defined in SOPs or by supervisor.

Formation

Master’s degree

Bachelor’s degree

Description du poste

Amgen Türkiye is seeking a LOCAL SAFETY OFFICER, SENIOR ASSOCIATE on a 1 year fixed contract to support Global Patient Safety activities in Türkiye. You will collect, process and submit safety reports, maintain compliance, and work with the Safety Country Lead to strengthen local pharmacovigilance.

The role involves training staff, assisting with audits and inspections, handling adverse event reporting, risk minimization, and contributing to safety initiatives across the local market.