International Pharmacovigilance (Pv) Manager (Apac)

TL;DR

International Pharmacovigilance (PV) Manager (APAC): Responsible for supporting and maintaining compliance with PV regulations for Vertex products throughout APAC with an accent on China. Focus on assessment of PV regulatory intelligence impacting APAC and China, and supporting readiness for China health authority inspections and internal audits.

Location: Remote, Hybrid, or On-Site. The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Ensure PV activities and GPS procedures are compliant with global and local PV regulations.
• Maintain working knowledge of evolving China GVP and NMPA PV expectations.
• Assess PV regulatory intelligence impacting APAC and China.
• Act as an operational liaison between GPS and the China DRP / MAH‑Delegate for routine PV activities.
• Support maintenance of China required PV documentation.
• Support GPS oversight of PV activities performed by MAH‑Delegate, DRP organization, and vendors.

Requirements

• 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.
• Excellent written and oral communication skills in English and Chinese.
• Strong understanding of China GVP and local PV execution practice.
• Experience working with local PV representatives, affiliates, or service providers in China.

Culture & Benefits

• Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.
• 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.