International Pharmacovigilance (PV) Senior Manager - APAC

Job Description

General Summary: The International Pharmacovigilance (PV) Senior Manager - APAC is a member of the Global Patient Safety (GPS) International Pharmacovigilance Team with sufficient authority to implement changes to Vertex’s PV Systems to promote, keep, and improve compliance with local regulatory requirements throughout APAC with an emphasis on China. The International PV Senior Manager role works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to confirm compliance with applicable regulatory requirements. This individual ensures that all work performed is in accordance with relevant regulatory guidelines. REQUIRED SKILLS Excellent written and oral communication skills in English and Chinese China PV experience Strong understanding of China GVP and local PV execution practice Experience working with local PV representatives, affiliates, or service providers in China KEY RESPONSIBILITIES Ensures that all PV activities and GPS procedures are compliant with global and local PV regulations Ensures required GPS contractual agreements are developed and finalized timely to support local and regional regulations Maintains expert‑level knowledge of China GVP and NMPA PV expectations Leads assessment of regulatory changes in China/APAC and determines impact to global and local PV systems May conduct presentations of safety issues, initiatives, and projects Provides input on effectiveness of the Quality Management System and when applicable, provides suggestions for improvement, including localization Ensures GPS has standards and processes in place to meet PV requirements at the local and regional levels Leads the development of Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to International PV and QPPV responsibilities Advises GPS leadership on APAC and China‑specific regulatory risks and mitigation strategies Provides oversight of APAC and China PV activities performed under delegated models in accordance with local requirements and internal GPS procedures Establishes and maintains clear oversight frameworks defining MAH vs MAH‑Delegate vs DRP responsibilities Acts as GPS interface with the China DRP and QPPV on PV governance, compliance status, and issue escalation Ensures appropriate management oversight is documented and inspection‑defensible Support the preparation, conduct, and responses to China health authority inspections in partnership with GPS Quality, Standards & Training (may support onsite PV inspections) Oversees development and maintenance of regional PV agreements with MAH‑Delegate, DRP entities, and vendors Leads build out and maintance of Vertex’s PV System into new APAC markets Represents GPS regarding patient safety related matters as assigned Performs other duties as assigned PREFERRED EDUCATION AND EXPERIENCE B.S. (or equivalent degree) and 7-8 years of relevant work experience in pharmaceutical industry setting in drug safety area, including China PV experience or Advanced degree (e.g.,PharmD, M.S.N or equivalent degree) and 6-7 years of relevant work experience in pharmaceutical industry setting in drug safety area, including China PV experience Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]