PrimeVigilance
Website:
primevigilance.com
Job details:
Company Description
Safety science and technology move forward here. So will you.
Prudentia, a PrimeVigilance company, is where safety science meets technology. We advise pharmaceutical companies on the processes and systems behind clinical and post-marketing safety, from selecting and implementing safety databases to managed services, data migration and turnkey tools that close the gaps in leading safety platforms.
It is specialist, high-trust work, and it depends on people who love solving hard problems. We are a team of curious minds, problem-solvers and experts brought together by a shared commitment to patient safety and to doing meaningful work well. Our culture values kindness, flexibility, growth and belonging, and we back one another to keep learning.
If you want a role with purpose, room to grow and the chance to make a real difference, we would love to hear from you.
Job Description
The Senior Principal Consultant - Validation leads enterprise‑level validation strategy by shaping frameworks,
harmonizing standards across portfolios, and ensuring global regulatory compliance while driving high‑risk
programs, organizational capability building, and long‑term CSV transformation with executive stakeholders.
Role And Responsibilities
- Assisting the authoring and execution of test scripts (OQ, PQ, UAT etc.)
- Independently developing test scripts
- Ability to assist in the development of validations deliverables
- Assisting in the development of migration deliverables (ie, queries for migration testing)
- Independently develop validation deliverables.
- Peer review test scripts against the requirements
- Assist in providing work effort estimates for testing phase
- Lead end-to-end the validation workstream for a internal/client project (planning, execution,
monitoring, closure)
- Assist in pre-sales activities (e.g., presentations, preparing proposals for clients
- Provide Subject Matter Expertise on current GxP regulations and standards (e.g., 21 CFR Part
11, EU Annex 11, GAMP)
- Co-leading pre-sales activities
- Lead audit readiness for internal/external audits
- Direct, supervise and mentor colleagues
Additional Responsibilities
- Apply CSV documentation standards
- Participate in test planning
- Independently develop validation deliverables
- Independently develop data migration validation deliverables
- Train Prudentia employees on CSV policies and deliverables
- Conduct validation knowledge transfer sessions for clients
- Direct and supervise L0 and L1 colleagues
- Manage project issues/risks and report to management
- Consult clients on validation approach
- Assist in CSV practice development such as developing templates, guides, and process improvement
(SOPs)
- Assist in audit readiness for internal/external audits
- Manage validation tracks across multiple projects
- Lead CSV practice development and process improvements
- Collaborate with cross-functional teams (ie, development, project management and quality) to ensure
quality considerations are incorporated into product development and policies and procedures
- Monitor CSV compliance against company's and regulatory requirements
- Assist the implementation of validation quality control measures / KPIs
- Practice Development (PD)
- Leads development of internal process docs (eg. SOPs) and training materials
- Leads development of articles, brochures, whitepapers, POVs
- Identifies required PD activities
- Estimates budget for PD activities
- Prioritizes PD activities
- Assign PD activities
- Recruiting
- Identify need for additional staff
- Provide guidance on job description
- Conduct interviews
- Sales
- Draft SOW
- Review MSA, NDA, License
- Lead proposal development
- Speaker at conferences
- Identify new opportunities with existing clients
- Admin
- Completes all admin tasks (e.g. time reporting, training records) timely with high quality
- Conduct appraisals for team members
- Review team T&E
- Setup project in Harvest
- Provide guidance for invoice generation
- Track invoice submission & payment
Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
Click on Apply to know more.
