Senior Consultant Validation (Pharmacovigilance projects)

The Senior Principal Consultant - Validation leads enterpriselevel validation strategy by shaping frameworks 
harmonizing standards across portfolios and ensuring global regulatory compliance while driving highrisk 
programs organizational capability building and longterm 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 companys 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 new 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. Youll 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. 

Remote Work :

No

Employment Type :

Full-time