In-Demand Biotechnology Jobs in Parramatta, Nsw

International Pharmacovigilance (PV) Senior Manager - APAC
Vertex Pharmaceuticals —Sydney NSW
- Full-time
- Hybrid work
- Master's degree
- Education
- Bachelor's degree
International Pharmacovigilance (PV) Manager - APAC
Vertex Pharmaceuticals —Sydney NSW
- Full-time
- Hybrid work
- Master's degree
- Education
- Bachelor's degree
Pharmacovigilance Project Manager (Japanese fluency required)
PrimeVigilance —Sydney NSW
- Full-time
- Leadership
Quick Apply
Senior Regulatory Affairs Manager
Sanofi —Sydney NSW
- Hybrid work
- Education
- Bachelor's degree
- AI
Post Market Lead
EBOS Group —North Ryde NSW
- Full-time
- Hybrid work
- Health insurance
- Parental leave
7d
Business Development Manager/Country Manager - Australia
GenePlanet —Sydney NSW
- Full-time
- Remote
- Sales
- Leadership
- Communication skills
Quick Apply
8d
Sr Legal and Compliance Counsel
Novo Nordisk —Sydney NSW
- Office
- Analysis skills
- In-person
1d
Postdoctoral Research Fellow in Extracellular Vesicle Analysis
Macquarie University —Macquarie University NSW
- $120,623 a year
- Full-time
- Doctoral degree
- Research
- University
23h
Service Sales & Support Specialist
Leica Microsystems —Lane Cove NSW
- Full-time
- Management
- Sales
- Salesforce
Commissioning Qualification Validation Engineer
PSC Biotech —Sydney NSW
- Full-time
- Customer service
- Engineering
- Laboratory experience
Regional Automation & Genomics Marketing Development Manager
Beckman Coulter Life Sciences —Lane Cove NSW
- Full-time
- Laboratory experience
- English
- Bachelor's degree
Senior Statistical Programmer I
Avance Clinical —Sydney NSW
- Full-time
- Microsoft Word
- Microsoft Excel
- Research
Quick Apply
Field Service Engineer
EBOS Group —Alexandria NSW
- Full-time
- Administrative experience
- Electrical experience
- Organisational skills
Commercial Account Executive – Health & Life Sciences (HLS)
Salesforce —Sydney NSW
- Full-time
- CRM software
- Sales
- Salesforce
- Parental leave
Business Support Coordinator
EBOS Group —Frenchs Forest NSW
- Full-time
- Administrative experience
- In-person
- Wellness program
- Health insurance
Territory Sales Manager - Australia East
Integrated DNA Technologies (IDT) —Lane Cove NSW
- Full-time
- CRM software
- Management
- Doctoral degree
Senior Technical Engineer
Watson Marlow Fluid Technology Solutions —Sydney NSW
- Management
- Maintenance
- Annual leave
- Parental leave
Computer System Validation (CSV) Specialist
CAI —Sydney NSW
- Full-time
- ERP systems
- AI
Quick Apply
Senior Technical Engineer
Watson-Marlow Fluid Technology Solutions —Sydney NSW
- Management
- Maintenance
- Annual leave
- Parental leave

Discover related jobs

Based on your search for biotechnology jobs.

Sales Representative (Medical and Pharmaceutical Products)
SUKO NORDIC AUSTRALIA PTY LTD —Parramatta NSW
Relevant tertiary qualification in Business, Commerce, Science or a related discipline. Monitor sales performance, market trends and competitor activity to…
From $95,000 a year
Quick Apply
7d
Research Assistant
University of Sydney —Westmead NSW
Hold a bachelor’s degree in a relevant field or an equivalent combination of training and experience (Neuroscience, Immunology, Molecular Biology or related).
$89,755 a year
5d

I want to receive the latest job alert for biotechnology in parramatta, nsw

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

biotechnology jobs near parramatta, nsw

Senior Counsel jobs in Sydney NSW

Postdoctoral Research Fellow jobs in Macquarie University NSW

Account Executive jobs in Sydney NSW

Regulatory Affairs Manager jobs in Sydney NSW

Business Development Manager jobs in Sydney NSW

Commissioning Engineer jobs in Sydney NSW

Regional Manager jobs in Victoria

Regional Manager jobs in Gold Coast Qld

Regional Manager jobs in Melbourne City Centre Vic

Regional Manager jobs in Western Australia

Regional Visa Sponsorship, Early Childhood jobs in Greater Adelaide Sa

Senior Speech Pathologist jobs in Victoria

Senior Counsel jobs in Virginia Qld

Senior Hr Business Partner jobs in Melbourne Vic

Senior Counsel jobs in Victoria

Senior Project Engineer jobs in Perth Wa

Senior Counsel jobs in New South Wales

Senior Structural Engineer jobs in Sydney Nsw

Senior Technical Engineer jobs in Mascot Nsw

Graduate Mechanical Engineer jobs in Sydney Nsw

International Pharmacovigilance (PV) Senior Manager - APAC

Vertex Pharmaceuticals -
Sydney NSW

Apply Now

Job Details

Full-time

Qualifications

Master's degree
Education
Bachelor's degree
Pharmacy
Chinese
Communication skills

Full Job 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 [email protected]

Apply Now

Refine Your Search

biotechnology jobs in parramatta, nsw

International Pharmacovigilance (PV) Senior Manager - APAC

International Pharmacovigilance (PV) Manager - APAC

Pharmacovigilance Project Manager (Japanese fluency required)

Senior Regulatory Affairs Manager

Post Market Lead

Business Development Manager/Country Manager - Australia

Sr Legal and Compliance Counsel

Postdoctoral Research Fellow in Extracellular Vesicle Analysis

Service Sales & Support Specialist

Commissioning Qualification Validation Engineer

Regional Automation & Genomics Marketing Development Manager

Senior Statistical Programmer I

Field Service Engineer

Commercial Account Executive – Health & Life Sciences (HLS)

Business Support Coordinator

Territory Sales Manager - Australia East

Senior Technical Engineer

Computer System Validation (CSV) Specialist

Senior Technical Engineer

Discover related jobs

I want to receive the latest job alert for biotechnology in parramatta, nsw

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected