Senior Consultant - Validation (Pharmacovigilance projects)
Skills
About the role
This is a senior computer system validation (CSV) consulting role at Prudentia, a PrimeVigilance company that advises pharmaceutical companies on safety systems and processes, based in Noida. It suits an experienced validation consultant who can lead validation workstreams, mentor colleagues and support pre-sales activity for pharmacovigilance-related projects. The role spans hands-on test script development through to leading validation strategy across client and internal projects.
What you’ll do
- Author and independently develop validation test scripts (OQ, PQ, UAT)
- Lead the validation workstream end-to-end for internal or client projects
- Peer review test scripts against requirements
- Provide subject matter expertise on GxP regulations such as 21 CFR Part 11, EU Annex 11 and GAMP
- Lead audit readiness for internal and external audits
- Direct, supervise and mentor colleagues
- Support pre-sales activities including proposals and client presentations
- Train staff on CSV policies and deliverables and consult clients on validation approach
What they’re looking for
- Experience authoring and developing validation test scripts and deliverables
- Subject matter expertise in GxP regulations and standards
- Experience leading validation workstreams across projects
- Experience mentoring or supervising junior colleagues
- Experience assisting in pre-sales and proposal development
Questions about this role
Is this role remote?
It's listed as hybrid, based in Noida, India.
What regulations does this role work with?
GxP standards including 21 CFR Part 11, EU Annex 11 and GAMP.
Related roles
Senior Submissions Officer
A senior pharmacovigilance submissions role at PrimeVigilance in Raleigh, NC, managing safety report submissions for pharmaceutical clients.
PV Officer (Medical Device & Product experience)
A pharmacovigilance officer role at PrimeVigilance in Pune, focused on medical device safety case processing.
Project Manager ( Pharmacovigilance )
A hybrid pharmacovigilance project management role in Noida, India, managing clusters of related safety projects. Suits an experienced project manager with a life sciences or healthcare background.
Sr. Consultant/Manager - Business Decision & AI Consultant
A business-first consulting role in Toronto pairing decision analysis with GenAI and agentic tooling. Suits an experienced analytics-minded consultant comfortable working directly with senior stakeholders.
Senior Strategy Consultant, Provider Solutions
A senior corporate strategy consultant role at VSP Vision, hybrid in the USA, supporting the CEO and Executive Team. Suited to strategy professionals with eight years of experience, ideally in vision, healthcare or insurance.
Senior Consultant, Financial Services-Insurance & Wealth & Asset Management
A senior consulting role at KPMG Canada in Toronto, working on strategy and operating-model transformation for insurance and wealth management clients.