Senior Principal Consultant

Parexel; Bengaluru; On-site; INR 6,500,000 - 9,000,000; Full time

Job summary

Parexel is seeking a Senior Principal Consultant to lead pharmacovigilance solution design and delivery. You will guide client engagements, manage safety data, and ensure regulatory compliance, while mentoring a team of consultants.

The role blends advanced pharmacovigilance practice with strategic technology delivery in a fast-paced environment. You will collaborate across clinical research, regulatory affairs, and data analytics, applying industry methodologies to drive client success and

Qualifications

• Bachelor’s or Master’s degree in computer science, information technology, or engineering.
• 11+ years of experience, including 5+ years in drug safety or clinical research consulting.
• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
• Experience with pharmacovigilance platforms such as Argus Safety, Insight, Mart, or similar systems.
• Extensive SQL/PLSQL coding experience.
• Deep knowledge of drug safety application implementation, upgrades and maintenance.

Responsibilities

• Analyze business needs and provide strategic guidance for drug safety solutions.
• Lead design and implementation of client engagements with high-quality, integrated software.
• Act as SME and thought leader on drug safety systems (Argus Safety, Insight, Mart, OBIEE, Axway).
• Mentor and manage a team of technical consultants and developers.
• Present solutions to customers and drive successful business implementation.
• Apply hands-on SQL/PLSQL to resolve complex technical challenges across modules.

Skills

Drug Safety

SQL/PLSQL

Argus Safety

Consulting

Leadership

Education

Bachelors/Masters in CS/IT/Engineering

Tools

Argus Safety

Insight

Mart

OBIEE

Axway EDI

Job description

When our values align, there’s no limit to what we can achieve.

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart(R).

About the Role

We are seeking a Senior Principal Consultant to join our team. As a consultant, you will drive the delivery of comprehensive drug safety solutions that protect patient well-being and ensure regulatory compliance. This position plays a key role in designing and implementing pharmacovigilance strategies, managing complex safety data, and providing expert guidance to clients on emerging safety issues and regulatory requirements. You’ll collaborate with cross-functional teams, apply industry-leading methodologies, and contribute to the successful execution of pharmacovigilance programs from initiation through ongoing monitoring.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advanced drug safety solutions and strategic client partnerships. With diverse teams and continuous learning opportunities, the Pharmacovigilance Consulting Services Lead can explore career paths and expand expertise across clinical research, regulatory affairs, and data analytics.

Key Responsibilities

• Analyze business needs and provide strategic guidance to ensure drug safety solutions meet customer objectives and drive successful project outcomes
• Lead solution design and implementation for client engagements, ensuring high-quality, integrated software solutions delivered within project constraints of time and budget
• Serve as a subject matter expert and thought leader, providing technical expertise in drug safety systems including Argus Safety, Insight, Mart, Analytics, OBIEE, and Axway EDI platforms
• Manage and mentor a team of technical consultants and developers, providing coaching, guidance, and feedback to develop team member skills and drive project success
• Present and demonstrate solutions to customers, influencing customer management in acceptance of solutions and ensuring successful business implementation
• Apply hands-on technical expertise in SQL and PL/SQL with strong troubleshooting skills across Argus, Axway, and associated modules to resolve complex technical challenges

You’ll thrive in this role if you bring:

• Strategic thinking and technical leadership capabilities to guide complex drug safety implementations
• Deep experience in drug safety systems, implementation methodologies, and best practices
• Strong SQL and PL/SQL programming skills with excellent troubleshooting and problem-solving abilities
• Proven ability to lead teams, mentor consultants, and collaborate effectively across organizations
• Excellent communication and presentation skills with the ability to influence stakeholder decisions

Required Qualifications

• Bachelor’s / master’s degree in computer science, information technology, or any engineering degree
• 11+ years of experience relevant to this position, including 5 years of consulting experience in drug safety or clinical research
• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
• Experience with pharmacovigilance platforms such as Argus Safety, Insight, Mart, or similar systems
• Extensive knowledge of writing SQL queries and PL/SQL code
• In‑depth knowledge of drug safety application implementation, upgrade, and maintenance
• Ability to craft and articulate strategic technology solutions that address complex business challenges

Preferred Qualifications

• Experience with E2B(R3) or EDI protocols for adverse event reporting
• Familiarity with additional pharmacovigilance analytics and visualization tools
• Experience in consulting or client-facing roles within the pharmaceutical industry

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.