Location: Bengaluru, Karnataka, India
Company: EY
Department: Regulatory Compliance – Pharmacovigilance
Job Type: Full-Time
Experience Required: 4–8 Years
Freshers Eligible: No
Salary: Competitive
Job ID: 1701999
About EY
EY is one of the world’s leading consulting and professional services organizations, helping businesses solve complex regulatory, technology, risk management, and compliance challenges across global industries. With operations in more than 150 countries, EY delivers innovative, AI-enabled, and technology-driven solutions for healthcare, life sciences, pharmacovigilance, and regulatory compliance sectors.
Job Overview – Senior Pharmacovigilance Case Processing Expert
EY is hiring experienced Pharmacovigilance professionals for the role of Senior Consultant – Regulatory Compliance – PV Business Analyst in Bengaluru. This opportunity is ideal for candidates with strong expertise in ICSR processing, drug safety operations, adverse event reporting, pharmacovigilance compliance, and safety database management.
The selected candidate will work closely with global drug safety teams, regulatory stakeholders, medical reviewers, and quality teams to ensure compliance with international pharmacovigilance regulations including FDA, EMA, ICH, and GVP guidelines.
This role offers extensive exposure to global pharmacovigilance operations, safety data management, compliance audits, regulatory inspections, and safety system implementation projects.
Key Responsibilities
Pharmacovigilance Case Processing & Drug Safety Operations
Perform end-to-end processing of Individual Case Safety Reports (ICSRs) from intake to submission
Receive and triage adverse event reports from healthcare professionals, patients, clinical trials, literature sources, and regulatory authorities
Conduct accurate data entry into pharmacovigilance databases including Oracle Argus, Veeva Vault Safety, and ArisGlobal systems
Evaluate case seriousness, expectedness, causality, and completeness according to global regulatory standards
Ensure timely expedited reporting of Serious Adverse Events (SAEs) as per FDA, EMA, ICH, and global reporting timelines
Collaborate with safety physicians and medical reviewers for case clarification and medical review support
Conduct reconciliation and quality control activities to maintain data integrity and compliance
Regulatory Compliance & Audit Readiness
Support global pharmacovigilance compliance activities and inspection readiness programs
Participate in internal audits, regulatory inspections, and client meetings
Maintain compliance with ICH-GCP, GVP modules, FDA regulations, EMA guidelines, and SOP requirements
Identify pharmacovigilance risks and proactively support mitigation strategies
Contribute to process improvement initiatives for operational efficiency and compliance excellence
PV Systems, Validation & Analytics
Support implementation and validation of pharmacovigilance safety systems including ARGUS, ArisG, and Veeva Safety
Prepare and review validation documentation such as validation plans, traceability matrices, test scripts, and validation reports
Collaborate with IT, QA, and Pharmacovigilance teams for system upgrades, troubleshooting, and enhancements
Create dashboards and analytical reports using Power BI and related reporting tools
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Nursing, or related healthcare field
4–8 years of hands-on experience in Pharmacovigilance Case Processing or Drug Safety Operations
Strong expertise in ICSR processing, SAE reporting, and global safety reporting requirements
Hands-on experience with Oracle Argus, Veeva Vault Safety, ArisGlobal, or similar PV databases
Strong understanding of FDA, EMA, ICH, and GVP pharmacovigilance regulations
Excellent analytical, communication, documentation, and problem-solving skills
Ability to work in a fast-paced, highly regulated global environment
Mandatory Skills
End-to-end Pharmacovigilance lifecycle management
Individual Case Safety Report (ICSR) processing expertise
Serious Adverse Event (SAE) reporting
Pharmacovigilance regulatory compliance
Drug safety database management
Signal detection and safety data analysis
Computer System Validation (CSV) for GxP systems
Power BI dashboard creation and PV analytics reporting
Audit and inspection readiness support
Cross-functional stakeholder collaboration
Preferred Skills
Literature screening experience for Japanese or global markets
Exposure to clinical trial safety reporting
Safety database testing and implementation projects
Pharmacovigilance certifications such as DIA or RAPS
Knowledge of risk management and signal detection activities
Why Join EY?
Opportunity to work with one of the world’s leading consulting organizations
Exposure to global pharmacovigilance and regulatory compliance projects
Career growth in life sciences consulting and drug safety operations
Collaborative work culture with international teams
Opportunities to work on AI-driven and data-enabled healthcare solutions
Continuous learning, mentorship, and leadership development programs
Who Should Apply?
This role is best suited for experienced Pharmacovigilance professionals seeking career growth in:
Drug Safety Operations
ICSR Processing
Pharmacovigilance Compliance
Regulatory Affairs
PV Technology & Safety Systems
Global Clinical Safety Operations
Freshers are not eligible for this position due to the advanced experience requirements in global pharmacovigilance case processing and regulatory compliance operations.
How to Apply
Interested candidates can apply through the official careers portal of EY or explore more global Pharmacovigilance and Clinical Research job opportunities on ThePharmaDaily.com.
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