Country Safety Lead(Pharmacovigilance, PV role)

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 Responsibilities:

• Act as Safety Responsible Person to establish and maintain the Marketing Authorization Holder (MAH) pharmacovigilance system aligned to global and local requirements for Biogen Korea LLC
• Ensures Health Authority submission compliance of Aggregate/periodic Reports; maintains an up-to-date knowledge of local regulatory requirements for Aggregate/periodic Reporting
• Responsible 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 vendors
• Authors 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 place

Essential Skills and Qualifications Required:

• 5+ years experience
• Valide pharmacist(or medical doctor) license
• In-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.