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)
o Leads development of internal process docs (eg. SOPs) and training materials
o Leads development of articles, brochures, whitepapers, POVs
o Identifies required PD activities
o Estimates budget for PD activities
o Prioritizes PD activities
o Assign PD activities

• Recruiting




o Identify need for additional staff
o Provide guidance on job description
o Conduct interviews

• Sales
o Draft SOW
o Review MSA, NDA, License
o Lead proposal development
o Speaker at conferences
o Identify recent opportunities with existing clients

• Admin
o Completes all admin tasks (e.g. time reporting, training records) timely with high quality
o Conduct appraisals for team members
o Review team T&E;
o Setup project in Harvest
o Provide guidance for invoice generation
o 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 cooperative 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.

📌 Senior Consultant - Validation (Pharmacovigilance projects) (India)
🏢 PrimeVigilance
📍 India