Senior Pharmacovigilance Case Processor - Regulatory Compliance

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Consultant– Pharmacovigilance Case Processing

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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

We are seeking a detail-oriented and experienced senior Pharmacovigilance Case Processing expert to join our global drug safety team. This role is essential in ensuring the accurate and timely processing of adverse event reports in compliance with global regulatory requirements. If you have a strong background in pharmacovigilance case intake, data entry, assessment, and submission, and are committed to patient safety and regulatory compliance, this position offers a great opportunity to contribute to the safety monitoring of pharmaceutical products worldwide.

Role Overview

As a Pharmacovigilance Case Processor, you will be responsible for the intake, processing, and quality review of individual case safety reports (ICSRs) from various sources not limiting to healthcare professionals, patients, and literature. You will ensure that all cases are accurately documented, assessed for seriousness and causality, and reported within regulatory timelines. You will work closely with cross-functional teams including medical reviewers, regulatory affairs, and quality assurance to maintain compliance with global pharmacovigilance regulations and standards.

Your key responsibilities

Client Responsibilities

• Represent clients during audits, inspections, and meetings with regulatory authorities.
• Receive and triage adverse event reports from multiple sources such as spontaneous reports, clinical trials, literature, and health authorities.
• Accurately enter case data into pharmacovigilance databases (e.g., Argus Safety, Veeva Vault Safety, ARISg) following established procedures and data standards.
• Perform initial case assessment including seriousness, expectedness, and causality evaluation according to company SOPs and regulatory guidelines.
• Ensure timely and accurate expedited reporting of serious adverse events to regulatory authorities in compliance with global timelines (e.g., FDA, EMA, ICH).
• Conduct quality control and reconciliation activities to ensure data integrity and completeness of case reports.
• Collaborate with medical reviewers and safety physicians to clarify case details and support medical review processes.
• Maintain up-to-date knowledge of pharmacovigilance regulations, guidelines, and industry best practices.
• Support audit and inspection readiness activities by maintaining accurate documentation and responding to queries.
• Participate in continuous process improvement initiatives to enhance case processing efficiency and quality.
• Provide training and guidance to junior case processors as needed.
• Collaborate with cross-functional teams, to ensure integrated safety strategies.

Skills and attributes for success

• Extensive knowledge of global PV regulations and guidelines, including ICH E2E, GVP Modules, FDA, EMA, and other international standards.
• Strong understanding of Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and related compliance frameworks.
• Ability to design and implement PV strategies aligned with business objectives and anticipate regulatory challenges.
• Excellent communication skills to convey complex safety and compliance information to stakeholders.
• Strong analytical and problem-solving skills for evaluating safety data, identifying signals, and interpreting regulatory trends.
• Ability to work collaboratively with cross-functional teams across clinical, regulatory, and quality domains.
• Precision and attention to detail in preparing safety reports, aggregate reports, and regulatory documentation.
• Proficiency with PV systems and tools such as Argus, ArisGlobal, Veeva Safety and emerging automation technologies.
• Ability to identify and mitigate PV-related risks and develop robust compliance strategies.
• Commitment to high ethical standards and adherence to all applicable laws and regulations.

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, Nursing, or related field.
• 4-8 years of experience in pharmacovigilance case processing or drug safety operations.
• Hands-on experience with pharmacovigilance databases such as Oracle Argus, Veeva Vault Safety, ArisG, or similar systems.
• Strong understanding of pharmacovigilance processes, adverse event reporting requirements, and regulatory timelines.
• Knowledge of global drug safety regulations including FDA, EMA, ICH guidelines.
• Detail-oriented with excellent data entry and organizational skills.
• 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 dashboard and PV related analytical reports creation using Power BI and similar tools
• Willingness to work flexible hours or shifts if required.

Must-Have Skills & Attributes

• Strong understanding of end-to-end Pharmacovigilance lifecycle, proven experience in processing individual case safety reports (ICSRs) from intake through submission.
• Familiarity with serious adverse event (SAE) reporting and expedited submission requirements.
• Ability to assess case data for completeness, accuracy, and regulatory compliance.
• Strong analytical and problem-solving skills to identify and resolve data discrepancies.
• Commitment to maintaining patient safety and data confidentiality.
• Excellent time management skills to meet strict reporting deadlines.
• End-to-end implementation and validation activities for pharmacovigilance safety systems such as ARGUS, ArisG, and Veeva Safety, ensuring compliance with regulatory requirements and internal quality standards
• Adaptability to changing regulatory requirements and company policies.
• Ability to develop and review validation documentation including validation plans, test scripts, traceability matrices, and validation reports to ensure system functionality, data integrity, and regulatory compliance.
• Collaborate with cross-functional teams including IT, Quality Assurance, and Pharmacovigilance to identify system requirements, troubleshoot issues, and support system upgrades and enhancements throughout the product lifecycle.
• Strong analytical and problem-solving skills to identify and resolve data discrepancies.
• Commitment to maintaining patient safety and data confidentiality.
• Excellent time management skills to meet strict reporting deadlines.

Good-to-Have Skills & Attributes

• Experience with literature screening and processing for Japanese clients.
• Knowledge of signal detection and risk management principles.
• Previous exposure to clinical trial safety reporting.
• 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 start–ups 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