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]
Apply To This Job
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]
Apply To This Job