Senior Associate II, Drug Safety (Pharmacovigilance)

About the role

The Senior Associate II, Drug Safety supports and facilitates the implementation and ongoing management of pharmacovigilance tasks for Biogen Türkiye, in line with local regulations, Biogen's global procedures and pharmacovigilance requirements. The role also acts as Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) and Local Contact for Pharmacovigilance (LCPPV) as per National Competent Authority guidelines.

Key responsibilities

• Support the implementation and maintenance of the local pharmacovigilance system under Turkish regulations and Biogen's global procedures.
• Act as Deputy Local QPPV, ensuring continuity of pharmacovigilance 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 to stay ready for inspections.
• Ensure compliance with local regulations, GVP requirements and internal quality standards.
• Support pharmacovigilance inspections and audits, including CAPA follow-up, and oversee external PV service providers.
• Collaborate with Medical Affairs, Regulatory Affairs, Quality and other affiliates, and with global and regional PV teams.
• Provide PV guidance, support training and act as a point of contact for local PV matters.

Required profile

• University degree in Medicine or Pharmacy, with the qualifications to act as a local Pharmacovigilance Appointee in Turkey.
• Physician or pharmacist registered, or eligible for registration, under local rules.
• 2-4 years of experience in pharmacovigilance or drug safety, preferably in the pharmaceutical industry.
• Fluency in Turkish and English, written and spoken; based in Turkey.

Required skills

• Good knowledge of Turkish pharmacovigilance regulations and GVP.
• Experience with local PV operations, safety reporting and regulatory compliance.
• Experience supporting PV audits, inspections and CAPA activities is an advantage; experience with external PV providers is preferred.
• Strong organizational, problem-solving and communication skills.