Senior Principal Consultant

Posted 8 Days Ago
Be an Early Applicant
2 Locations
In-Office
Senior level
Pharmaceutical
The Role
Leads drug safety consulting engagements, designing and implementing pharmacovigilance solutions, advising clients on regulatory and safety requirements, and resolving complex technical challenges across Argus and related platforms. Provides strategic guidance, presents solutions to stakeholders, and manages and mentors technical consultants and developers. Requires deep drug safety systems expertise, SQL and PL/SQL proficiency, consulting experience, and knowledge of clinical trial and ICH-GCP requirements.
Summary Generated by Built In

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.


If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!

Skills Required

  • Bachelor's or master's degree in computer science, information technology, or engineering
  • 11+ years of relevant experience, 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, upgrades, and maintenance
  • Ability to craft and articulate strategic technology solutions for complex business challenges
  • 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

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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