Deputy Local QPPV & Drug Safety Specialist

Biogen, Inc.; Fatih; On-site; TRY 600,000 - 900,000; Full time

Job summary

Biogen Türkiye is seeking a Sr. Associate II, Drug Safety to support and manage pharmacovigilance tasks in compliance with Turkish regulations and Biogen global procedures. The role also acts as deputy QPPV, ensuring continuity of PV activities and coverage when required.

You will coordinate local safety activities, maintain PV documentation, and partner with Medical Affairs, Regulatory, and Quality to align local and global processes while driving patient safety and inspection readiness.

Qualifications

• University degree in Medicine or Pharmacy with local QPPV eligibility.
• Licensed physician or pharmacist, or eligible for registration in Türkiye.
• 2–4 years in pharmacovigilance or drug safety.
• Knowledge of Turkish PV regulations and GVP.
• PV audits/inspections experience a plus.
• Experience with external PV service providers preferred.
• Strong organizational and communication skills.
• Turkish and English fluency.

Responsibilities

• Support local PV system implementation and maintenance per Turkish regulations and Biogen global procedures.
• Act as Deputy Local QPPV, ensuring continuity of PV activities and coverage when required.
• Coordinate local safety activities, including adverse event reporting, safety information exchange, and regulatory submissions.
• Maintain local PV documentation, procedures, and records for inspection readiness.
• Ensure compliance with local PV regulations and GVP.
• Support pharmacovigilance inspections and CAPA activities.
• Oversee external pharmacovigilance service providers and monitor performance and compliance.
• Collaborate with Medical Affairs, Regulatory, Quality and affiliate functions to coordinate safety activities.

Skills

Turkish fluency

English fluency

Strong communication

Education

Medicine or Pharmacy degree

Job description

Biogen Türkiye is seeking a Sr. Associate II, Drug Safety to support and manage pharmacovigilance tasks in compliance with Turkish regulations and Biogen global procedures. The role also acts as deputy QPPV, ensuring continuity of PV activities and coverage when required.

You will coordinate local safety activities, maintain PV documentation, and partner with Medical Affairs, Regulatory, and Quality to align local and global processes while driving patient safety and inspection readiness.