International Pharmacovigilance (PV) Senior Manager - APAC at Vertex Strategies Inc

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

0.0

Posted On

22 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, China GVP, Regulatory Compliance, English Proficiency, Chinese Proficiency, NMPA Regulations, Quality Management System, SOP Development, Risk Mitigation, Inspection Readiness, Vendor Oversight, APAC Regulatory Affairs

Industry

Software Development

Description

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 ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

Responsibilities

Lead the implementation and improvement of Pharmacovigilance systems across the APAC region, with a primary focus on China compliance. Manage regulatory risks, develop SOPs, and oversee safety activities performed by delegates and vendors to ensure inspection-defensible documentation.