International Pharmacovigilance (PV) Manager - APAC

Job Description

General Summary: The International Pharmacovigilance (PV) Manager – APAC is a member of the Global Patient Safety (GPS) International Pharmacovigilance Team who is responsible for supporting and maintaining compliance with PV regulations for Vertex products throughout APAC with an emphasis on China.. The Manager role operates with a high degree of independence, applies regulatory knowledge to practical execution, and escalates risks appropriately to GPS leadership. 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 in a timely manner to support local and regional regulations Maintains working knowledge of evolving China GVP and NMPA PV expectations Responsible for assessment of PV regulatory intelligence impacting APAC and China Provides input on effectiveness of the Quality Management System and when applicable, provides suggestions for improvement, including localization Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs) with minimal supervision Acts as an operational liaison between GPS and the China DRP / MAH‑Delegate for routine PV activities Supports maintenance of China required PV documentation (e.g., PSMF sections, annexes, role descriptions, training records) Supports GPS oversight of PV activities performed by MAH‑Delegate, DRP organization, and vendors Reviews PV metrics, compliance reports, and issue logs; escalates deviations, risks, or delays Participates in vendor/partner meetings related to PV execution Supports readiness for China health authority inspections and internal audits (may support onsite PV inspections) Supports 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 5 – 6 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 4 – 5 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]