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-EligibleFlex 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]
Skills Required
- B.S. or equivalent degree and 5 - 6 years of relevant work experience in drug safety area
- Advanced degree (PharmD, M.S.N or equivalent) and 4 - 5 years of relevant work experience in drug safety area
- Excellent written and oral communication skills in English and Chinese
- Strong understanding of China GVP and local PV execution practice
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
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Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
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Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
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Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
