Country Safety Lead, Korea

The Country Safety Lead (CSL) is the primary Pharmacovigilance (PV) point of contact for the local territory, fulfilling the regulatory mandated role of the Local Qualified Person for Pharmacovigilance (LQPPV) in Korea. The CSL is responsible for the end-to-end setup, operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The CSL is a key strategic partner for the local business and provides valued consultation and collaboration to all affiliate stakeholders and global functions to support local, regional and global objectives. The CSL also contributes to the Global and Regional PV strategy as required.Key ResponsibilitiesAct as Safety Responsible Person to establish and maintain the Marketing Authorization Holder (MAH) pharmacovigilance system aligned to global and local requirements for Biogen Korea LLCEnsures Health Authority submission compliance of Aggregate/periodic Reports; maintains an up-to-date knowledge of local regulatory requirements for Aggregate/periodic ReportingResponsible for the identification of outsourcing needs and the recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors, Service Providers and other third parties; ensures alignment with applicable global oversight strategies for vendorsAuthors local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements, and ensures content alignment with GSRS procedures and Local PV requirements; ensures regular updates of these documents as per the established review cycles and as required according to enhancement needs.Acts as the primary contact and Subject Matter Expert (SME) for local Audits and as required for local HA Inspections (including the interviewee role and collating responses to document requests); plays a lead role in the facilitation and coordination of local audits and inspections in collaboration with the applicable Quality teams; ensures there is timely and appropriate communication throughout the life-cycle of the Audit or Inspection to key Local and Global stakeholders including International PV (IPV); contributes as required to the Global Auditing strategy as it relates to the local territory.Utilize core/reference RMPs and other sources to produce local Risk Management Plans (RMPs) in accordance with local requirements. Engage with relevant stakeholder in the development of local Risk Minimization Measures (RMMs) and RMP Commitments as needed.Manage engagement of pharmacovigilance operations vendors as established in global procedure and aligned to contractual agreement in placeEssential Skills And Qualifications Required5+ years experienceValide pharmacist(or medical doctor) licenseIn-depth knowledge of Global, Regional and local PV regulations and requirements.Excellent written and verbal communication skills including: Well-developed technical writing skills with the ability to produce clear, concise documentation and communications.+Good presentation and analytical skills.Excellent Project Management skills.Proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.Must work effectively/collaboratively in a fast-paced and matrixed environment.Individual has effective managerial skills (as applicable to job role and scope), is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize.Strong decision-making skills required.Must demonstrate initiative to effectively identify and communicate issues.Individual should be able to demonstrate innovative thinking.Job Level: ProfessionalWhy 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 our DE&I efforts.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.