Job Title: Regulatory Review Advisor – Patient Safety
Location: Bangalore, India
Job Requisition ID: R-244642
Employment Type: Full-Time
Grade: C2
Experience Required: 5–8 Years (Pharmacovigilance & Regulatory Reporting)
Application Deadline: 27 February 2026
Regulatory Review Advisor – Patient Safety | Pharmacovigilance Regulatory Reporting Jobs in Bangalore
AstraZeneca is hiring a Regulatory Review Advisor – Patient Safety in Bangalore, India. This is a senior-level pharmacovigilance role focused on global regulatory reporting compliance, adverse event submissions, and audit readiness in alignment with Good Pharmacovigilance Practices (GVP).
The position is ideal for experienced drug safety and regulatory professionals with expertise in ICSR submissions, aggregate safety reports, global health authority requirements, and inspection readiness.
Role Overview: Global Regulatory Reporting & Patient Safety Compliance
The Regulatory Review Advisor will serve as a key subject matter expert responsible for ensuring accurate, timely, and inspection-ready regulatory submissions to global health authorities. The role involves translating evolving pharmacovigilance regulations into standardized internal processes while minimizing compliance risk.
This position requires strong knowledge of global PV regulations, safety databases, aggregate reporting, and cross-functional stakeholder coordination.
Key Responsibilities
Regulatory Reporting Compliance
Ensure timely and accurate submission of Adverse Event Reports, Periodic Safety Update Reports (PSURs), and other regulatory documents
Interpret and apply global regulatory reporting requirements across regions
Monitor changes in pharmacovigilance guidelines and align internal processes accordingly
Maintain complete, audit-ready documentation for inspections
Adverse Event & Safety Reporting
Oversee pharmacovigilance reporting activities in compliance with Good Pharmacovigilance Practices (GVP)
Coordinate assessment, processing, and submission of Individual Case Safety Reports (ICSRs) within defined timelines
Support signal detection and risk assessment activities
Collaborate with Quality Assurance, Medical Affairs, and Patient Safety teams to ensure regulatory alignment
Training & Process Excellence
Provide regulatory reporting training and mentorship to internal teams
Support regulatory audits and inspections, including corrective and preventive action (CAPA) implementation
Contribute to continuous process improvement initiatives to enhance reporting efficiency and compliance reliability
Operational Readiness & Governance
Maintain in-depth knowledge of country-specific regulatory requirements and global PV guidance documents
Ensure compliance with safety-related product commitments and obligations
Support external service providers in meeting company and local PV requirements
Maintain proficiency in safety databases, regulatory systems, and quality management platforms
Essential Experience & Skills
5–8 years of experience in pharmacovigilance regulatory reporting or drug safety operations
Strong knowledge of global health authority reporting requirements
Experience in ICSR submissions and aggregate safety reporting
Hands-on experience with safety databases and regulatory systems
Familiarity with MedDRA and WHODrug coding standards
Proven experience supporting or leading regulatory audits and inspections
Strong documentation, compliance, and risk management capabilities
Excellent cross-functional collaboration skills
Desirable Skills
Experience with Argus, ArisGlobal, E2B submissions, and EudraVigilance reporting
Process standardization and automation exposure
CAPA planning and implementation experience
Ability to translate evolving regulatory requirements into clear operational guidance
Work Model
AstraZeneca follows a hybrid working model with an expectation of approximately three days per week in-office, while maintaining flexibility.
Why Join AstraZeneca?
At AstraZeneca, regulatory excellence directly contributes to patient safety and accelerated access to innovative therapies. The organization fosters a science-driven, collaborative culture supported by automation, data insights, and continuous learning. Professionals in this role gain exposure to global regulatory frameworks while contributing to high-impact patient safety initiatives.
Equal Opportunity Statement
AstraZeneca is committed to diversity, equity, and inclusion. Applications are welcomed from qualified candidates of all backgrounds in accordance with applicable non-discrimination laws and employment regulations.
Apply now on ThePharmaDaily.com to advance your career in global pharmacovigilance, regulatory reporting compliance, and patient safety leadership.
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