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Novartis is hiring an Aggregate Reports & Risk Management Analyst for its Hyderabad office. This full-time pharmacovigilance role supports global Aggregate Reporting (AR) and Risk Management (RM) activities, ensuring regulatory compliance, audit readiness, and high-quality safety documentation across the product lifecycle.
This opportunity is ideal for professionals with experience in pharmacovigilance, aggregate safety reports, risk management systems, and regulatory compliance, looking to work in a global, innovation-driven environment.
🔑 Key Responsibilities
- Support preparation of aggregate safety and risk management reports (PSUR, PBRER, RMP-related activities)
- Retrieve and analyze data from global safety databases as per Novartis SOPs
- Perform quality control (QC) checks ensuring accuracy, consistency, and regulatory compliance
- Manage scheduling, tracking, dispatch, and archival of AR & RM deliverables
- Coordinate with licensing partners to meet joint safety obligations
- Support RCA, CAPA, and quality incident management
- Ensure inspection and audit readiness, including documentation archival
- Handle AR & RM mailboxes (inbound and outbound communications)
- Act as Super User for safety tools and systems
- Prepare metrics, dashboards, and compliance trackers for management review
- Support automation, AI initiatives, and operational excellence projects
- Contribute to PV Master File (PSMF) and PS&PV quality metrics
- Train and onboard new team members on AR & RM processes
- Maintain SharePoint, trackers, and shared drives
- Adhere strictly to Good Documentation Practices (GDocP)
🎓 Qualifications & Skills
Education & Experience
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- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline
- Experience in Pharmacovigilance, Aggregate Reporting, or Risk Management preferred
Key Skills
- Pharmacovigilance & Safety Science
- Aggregate Reports & Risk Management
- Regulatory compliance & audit readiness
- Safety databases & reporting tools
- Documentation, tracking & metrics reporting
- Project coordination & stakeholder collaboration
Desired Competencies
- Strong attention to detail
- Knowledge of global PV regulations
- Excellent communication & coordination skills
💼 Why Join Novartis?
- Work on global pharmacovigilance programs
- Exposure to EU QPPV Office & senior leadership reporting
- Strong focus on automation, AI, and digital transformation
- Career growth in drug safety, compliance, and risk management
- Inclusive, quality-driven, and innovation-focused culture
📍 Job Location
Hyderabad (Office-based), India
💰 Salary (Indicative)
₹6,00,000 – ₹10,00,000 per annum
(Based on experience, skills, and internal benchmarks)
📝 How to Apply
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