Overview
Associate Director, Global Medical Information – Global Operations at Kyowa Kirin International plc, Marlow, UK (hybrid).
WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE. At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose: You will play a critical role in oversight and management of the day-to-day operational activities of the Global Medical Vault as it relates to the Standard Operating Procedures, Global contact centres, the Global Medical Information Inquiry Management System (VEEVA), Global Medical Material, Medical Vault training needs. This position will be a Global SME of VEEVA data entry, case coding, quality review and of all Medical Information inquiries as it relates to all products and activities within Medical Information
Responsibilities
* Assure the safe and effective use of Kyowa Kirin products
* Support management of all regional medical information daily activities related to the GMI operations and contact centers
* Support the coordination of medical material review from a global to regional to local perspective
* Work with regional MA colleagues, GPV and vendor(s) to manage internal communications network (phonelines/IVR) on behalf of GMI
* Cross functional working with drug safety and quality assurance departments to carry out monthly quality monitoring of cases received and reconcile adverse events/product quality complaints
* Support Head of Global Medical Information to ensure that the service is delivered in compliance with the applicable national and regional codes and practices
* Supports the VEEVA business system administrators in requests for access to VEEVA and provide oversight of VEEVA system
* Provide support in audits and inspections across the regions
* Represent the Global Medical Information function in cross-regional and global project teams and provide input into relevant processes as needed
* Ensure adherence to all applicable SOPs, policies, processes, and compliance guidelines
Qualifications
* Position Requirements:
* Advanced degree in Health Sciences or significant experience in related fields is highly preferred
* Significant direct industry experience in Medical Information at pharmaceutical companies or medical communication agencies
* In depth knowledge about regulations pertaining to Medical Information, pharmacovigilance a relevant functions across all KK MI regions
* Direct experience in above country medical information experience is a requirement
* SME level understanding of Veeva MedInquiry
* Professional experience in medical information inquiry tracking and medical material review systems
* Extensive experience in global and regional vendor management
* Experience in contact center telephony system management and structure
Kyowa Kirin International is an equal opportunities employer.
No agencies please.
#J-18808-Ljbffr