Senior Validation Analyst Veeva EDC

ICON Strategic Solutions; Chennai; Hybrid; INR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Employee assistance program

Annual leave entitlements

Retirement planning

Job summary

ICON Strategic Solutions is seeking a Senior Validation Analyst (Veeva EDC) to oversee validation plans and ensure regulatory compliance across software, systems and processes. The role is office or home based in India, with travel as needed.

You will collaborate with IT, QA, and operations to establish validation best practices, perform risk assessments, and document all validation activities to support audits. Strong analytical and communication skills are essential for success.

Qualifications

• Strong analytical and problem-solving abilities with meticulous attention to detail.
• Effective written and verbal communication across cross-functional teams.
• Willingness to travel as required (about 5%).

Responsibilities

• Lead validation activities for software, systems, and processes to ensure regulatory compliance.
• Collaborate with IT, QA and operations to define validation needs and best practices.
• Perform risk assessments and impact analyses to guide validation strategies.
• Document validation activities and maintain audit-ready records.

Skills

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's degree in Life Sciences/Engineering/CS

Job description

Job Description:

Senior Validation Analyst (Veeva EDC) - Office or Home based

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Validation Analyst at ICON, you will be responsible for ensuring that all systems and processes comply with regulatory standards and internal quality requirements.

What You Will Do

You will lead on scientific operations tasks requiring technical depth, with a focus on quality and continuous improvement.

Key Responsibilities Include

• Developing and executing validation plans, protocols, and reports for software, systems, and processes to ensure compliance with regulatory requirements.
• Collaborating with IT, QA, and operational teams to assess validation needs and establish best practices in validation methodologies.
• Conducting risk assessments and impact analyses to identify potential issues and recommend appropriate validation strategies.
• Documenting validation activities and maintaining accurate records to support audits and inspections.
• Providing training and guidance to junior analysts, fostering a culture of quality and compliance within the team.

Your Profile

You will have a strong foundation in scientific operations, with the experience to work independently and guide others.

Required Qualifications And Experience

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field.
• Extensive experience in validation activities within the healthcare, pharmaceutical, or clinical research sectors.
• Strong knowledge of regulatory requirements (e.g., GxP, FDA, EMA) and validation best practices.
• Excellent analytical and problem-solving skills, with a keen attention to detail and accuracy.
• Effective communication skills, with the ability to collaborate with cross-functional teams and convey complex information clearly.
• Willingness to travel as required (approximately 5%).

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here