Novartis is inviting applications for the position of Aggregate Reports & Risk Management (AR&RM) Analyst to support pharmacovigilance reporting and safety science operations. This role focuses on managing aggregate safety reports, risk management deliverables, pharmacovigilance documentation, and regulatory compliance activities within the development portfolio.
Professionals with experience or interest in pharmacovigilance reporting, safety data management, aggregate reports, and risk management processes will find this opportunity valuable to build a career with a leading global pharmaceutical company.
The position supports preparation, scheduling, quality review, compliance tracking, audit readiness, and coordination of pharmacovigilance deliverables across global safety systems and databases.
Job Overview
Position: Aggregate Reports & Risk Management Analyst
Department: Pharmacovigilance / Safety Science
Employment Type: Full-Time
Application Deadline: 9 March 2026
Industry: Pharmaceutical / Pharmacovigilance / Drug Safety
Key Responsibilities
The selected candidate will support pharmacovigilance and risk management operations including:
Aggregate Reports & Pharmacovigilance Reporting
- Assist in preparation of aggregate safety reports and risk management deliverables
- Retrieve safety data from global pharmacovigilance databases as per SOPs
- Perform quality control (QC) checks to ensure regulatory compliance
- Support preparation and dispatch of pharmacovigilance reports
Risk Management & Compliance
- Support CAPA, RCA, and quality incident management
- Assist in audit and inspection readiness
- Maintain compliance with global pharmacovigilance regulations and Novartis standards
Operational Coordination
- Coordinate with licensing partners and internal stakeholders
- Manage report scheduling, tracking tools, and documentation systems
- Handle inbound and outbound AR&RM mailbox communications
Metrics, Documentation & Tracking
- Prepare pharmacovigilance metrics and compliance reports
- Maintain tracking tools, SharePoint systems, and safety documentation
- Support PV Master File documentation and quality metrics reporting
Technology & Automation
- Participate in automation initiatives and AI-driven safety tools
- Support testing of safety systems and IT applications
Training & Administrative Support
- Train new team members on AR&RM processes
- Maintain Good Documentation Practices (GDP)
- Support general administrative activities for AR&RM operations
Key Skills Required
Candidates applying for this pharmacovigilance job should have knowledge of:
- Pharmacovigilance reporting and safety science
- Aggregate safety reports and risk management plans
- Global pharmacovigilance databases
- Regulatory compliance and SOP adherence
- Good Documentation Practices (GDP)
- CAPA and quality incident management
- SharePoint and safety tracking tools
- Data reporting and safety metrics analysis
- Project management and documentation systems
Qualifications
Preferred qualifications include:
- B.Pharm / M.Pharm / Pharm.D / Life Sciences degree
- Knowledge of pharmacovigilance operations and safety reporting
- Familiarity with ICH guidelines and PV regulatory requirements
- Strong analytical, documentation, and reporting skills
- Experience working with safety databases and reporting systems
Freshers with strong pharmacovigilance knowledge may also be considered depending on the organizationโs hiring criteria.
Key Performance Indicators (KPIs)
The AR&RM Analyst will be evaluated based on:
- Timely tracking and reporting of pharmacovigilance deliverables
- Accuracy and completeness of safety documentation
- Compliance with global pharmacovigilance standards
- Effective project coordination and risk management activities
- Audit and inspection readiness
Benefits of Working at Novartis
Working with Novartis provides professionals access to:
- Global exposure in pharmacovigilance and safety science
- Opportunities to work on risk management and aggregate safety reports
- Exposure to advanced pharmacovigilance systems and AI initiatives
- Collaborative work environment with global safety teams
- Career growth in drug safety, PV operations, and regulatory compliance
How to Apply
