RC-REGULATORY COMPLIANCE-PV-CA-Veeva-Senior

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Consultant– Veeva Vault Safety – Configuration Specialist 

At EY, we’re all in to shape your future with confidence. 

We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.  Join EY and help to build a better working world.

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

This role offers the opportunity to work on global pharmacovigilance technology and regulatory compliance transformation programs across multiple jurisdictions. You will support clients in strengthening patient safety, inspection readiness, and system governance, directly contributing to EY’s purpose of Building a better working world.

Role Overview

As a Veeva Safety Configuration Specialist, you will be responsible for configuring, validating, and governing Veeva Vault Safety solutions to support end‑to‑end pharmacovigilance processes, ensuring alignment with global regulatory expectations and client SOPs.

Your key responsibilities

Client Responsibilities

• Configure Veeva Vault Safety workflows, lifecycles, objects, templates, and business rules supporting intake, triage, case processing, review, and submissions.
• Understand global PV regulations and client SOPs into GxP compliant system configurations.
• Design and maintain role based security and access controls aligned with data integrity and privacy expectations.
• Liase with CSV teams wherever required.
• Represent clients during audits, inspections, and regulatory interactions related to pharmacovigilance systems.
• Support audit and inspection readiness activities and respond to regulatory and quality queries.
• Collaborate with Pharmacovigilance, Quality Assurance, IT, and Regulatory stakeholders for larger business success.
• Mentor junior team members and contribute to EY internal initiatives.

Skills and attributes for success 

• Strong understanding of global pharmacovigilance regulations including ICH, GVP, FDA, and EMA.
• Hands on experience with Veeva Vault Safety configuration in regulated environments.
• Strong GxP and computer system validation knowledge.
• Excellent stakeholder communication and consulting skills.
• Strong analytical and risk‑based problem-solving capabilities

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, Nursing, or related field.
• 4-8 years of experience with pharmacovigilance systems with hands‑on exposure to Veeva Vault Safety configuration and validation.
• Strong understanding of pharmacovigilance processes, adverse event reporting requirements, and regulatory timelines.
• Experience working in consulting or global delivery models supporting regulated life sciences clients
• Knowledge of global drug safety regulations including, but not limited to FDA, EMA, ICH guidelines.
• Ability to work independently and as part of a team in a fast-paced, regulated environment.
• Strong communication skills to interact effectively with internal teams and external stakeholders.
• Proficiency for dashboards to communicate and understand relevant data to Business.
• Willingness to work flexible hours or shifts if required.

Must-Have Skills And Attributes

• Ensuring GxP compliant configurations for case processing and regulatory submissions.
• Core Veeva Vault Safety configuration (workflows, lifecycles/state models, objects/fields, templates, business rules, data model governance).
• Security & access control (roles, permission sets, sharing rules, dynamic access, segregation of duties).
• Integrations and interfaces (Vault APIs/connectors, intake channels, E2B(R3), data migration support).
• Reporting & analytics (Vault reports/dashboards, operational KPIs, data quality checks, compliance monitoring).
• Pharmacovigilance domain understanding (ICSR processing, MedDRA/WHO‑DD awareness, seriousness/expectedness, regulatory timelines etc).
• Requirements & solution design (process mapping, URS/FRS, configuration specifications, prototyping, Agile delivery tools).
• Overall understanding of Testing & validation.
• Stakeholder, documentation and project skills (communication, training/enablement, change management, handover, governance support).

Good-to-Have Skills And Attributes

• Experience in working for Japanese clients with understanding of latest regulatory requirements for PMDA.
• Knowledge of PV workflow and processes.
• Safety Database testing and implementation.
• Certification in pharmacovigilance or drug safety (e.g., DIA, RAPS) is a plus.
• Computer system validation of GxP systems and creation/review of system documentation.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers 

At EY, we’re dedicated to helping our clients, from startups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you