Sr Consultant
PrimeVigilance · Noida · onsite · Posted 42d ago
About a minute. You'll make an account on the way through.
About this role
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.
- 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
- 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
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
o Identify need for additional staff
o Provide guidance on job description
o Conduct interviews
o Draft SOW
o Review MSA, NDA, License
o Lead proposal development
o Speaker at conferences
o Identify new opportunities with existing clients
o Completes all admin tasks (e. g. time reporting, training records) timely with high quality
o Conduct appraisals for team members
o Review team TE
o Setup project in Harvest
o Provide guidance for invoice generation
o Track invoice submission payment
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
About PrimeVigilance
PrimeVigilance
501-1000
employees
2008
18 years old
Guildford
United Kingdom
₹9.7L PA avg
Avg at PrimeVigilance
About
PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.
From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
• 900+ highly qualified professionals
• Global leader in QPPV services
• 24/7 multilingual call center
• Choice of leading drug safety databases
• Robotic Process Automation (RPA) expertise
• Access to regulatory experts and key opinion leaders
GLOBAL LIFE CYCLE MANAGEMENT SERVICES
• PHARMACOVIGILANCE
• PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT
• AUDIT & INSPECTION
• QUALITY MANAGEMENT
• REGULATORY SCIENCE
Industries
Employee ratings
9 reviews
Culture
3.4
Career growth
2.9
Work-life
3.7
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