About This RoleThe Sr. Associate II, Drug Safety supports and facilitates the implementation and ongoing management of Pharmacovigilance tasks as it relates to Biogen Türkiye in compliance with applicable local regulations, Biogen global procedures and Pharmacovigilance requirements.
The Sr. Associate II, Drug Safety also acts as the deputy Qualified Person for Pharmacovigilance (QPPV) Local contact for Pharmacovigilance (LCPPV) as per National Competent Authority guidelines.
What You'll DoLocal Pharmacovigilance Operations- Support the implementation and maintenance of the local pharmacovigilance system in accordance with Turkish regulations and Biogen's global procedures.
- Act as Deputy Local QPPV, ensuring continuity of pharmacovigilance activities and appropriate 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 ensure ongoing inspection readiness.
Compliance, Quality & Vendor Oversight- Ensure compliance with applicable local pharmacovigilance regulations, GVP requirements, and internal quality standards.
- Support pharmacovigilance inspections and audits, including preparation, follow-up activities, and corrective and preventive actions (CAPAs).
- Oversee external pharmacovigilance service providers, monitoring performance, deliverables, and compliance with contractual obligations.
- Identify potential compliance gaps and contribute to continuous improvement initiatives.
Cross-Functional Collaboration- Partner with Medical Affairs, Regulatory Affairs, Quality, and other affiliate functions to ensure effective coordination of safety-related activities.
- Collaborate with global and regional pharmacovigilance teams to ensure alignment between local requirements and global processes.
- Provide pharmacovigilance guidance and support relevant training activities for local stakeholders.
- Serve as a point of contact for local PV matters and contribute to effective communication with relevant external stakeholders.
Who You AreYou are a proactive and detail-oriented pharmacovigilance professional with a strong understanding of local drug safety regulations and compliance requirements. You are comfortable taking ownership of responsibilities, working independently, and collaborating with cross-functional teams and external partners. With strong organizational and communication skills, you thrive in a dynamic environment and are committed to ensuring patient safety, regulatory compliance, and continuous improvement.
Required Skills- University degree in Medicine or Pharmacy, with the qualifications required to act as a local Pharmacovigilance Appointee in Türkiye.
- Physician or pharmacist registered, or eligible for registration, in accordance with local regulatory requirements.
- 2-4 years of relevant experience in pharmacovigilance or drug safety, preferably within the pharmaceutical industry.
- Good knowledge of Turkish pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).
- Ability to act as Deputy Local Pharmacovigilance Appointee, ensuring continuity of pharmacovigilance activities and compliance with local regulatory requirements.
- Experience with local pharmacovigilance operations, safety reporting, and regulatory compliance.
- Experience supporting pharmacovigilance audits, inspections, and CAPA activities is an advantage.
- Experience working with external pharmacovigilance service providers is preferred.
- Strong organizational, problem-solving, and communication skills.
- Fluency in Turkish and English, both written and spoken.
- Based in Türkiye.
Job Level: Professional
Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
