Novartis Hiring Aggregate Reports & Risk Management Analyst | Pharmacovigilance Job in Hyderabad

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Aggregate Reports & Risk Management Analyst

Novartis

Hyderabad

Pharmacovigilance

Aggregate Reporting

Risk Management

Full-Time

🏢 About Novartis

Novartis is a global healthcare leader focused on innovative medicines and digital transformation. With strong global pharmacovigilance systems and EU QPPV oversight, Novartis operates at the forefront of drug safety and compliance.

The company integrates automation, AI, and advanced safety science to ensure global regulatory compliance across product lifecycles.

📌 Job Overview

Novartis is hiring an Aggregate Reports & Risk Management Analyst for its Hyderabad office.

This role supports PSUR, PBRER, RMP activities, risk management systems, regulatory submissions, quality tracking, and audit readiness within the global Pharmacovigilance framework.

Ideal for professionals experienced in Aggregate Reporting, Safety Databases, and Global PV Compliance.

🧪 Key Responsibilities

Support preparation of PSUR, PBRER, and RMP safety reports
Retrieve and analyze data from global safety databases
Perform QC checks for accuracy, consistency & regulatory compliance
Manage scheduling, tracking & dispatch of AR & RM deliverables
Coordinate with licensing partners on joint safety obligations
Support RCA, CAPA & quality incident management
Ensure audit & inspection readiness
Maintain AR & RM mailboxes & communications
Act as Super User for safety systems
Prepare compliance dashboards & management reports
Contribute to PV Master File (PSMF) documentation
Support automation & AI-based PV initiatives
Train new joiners on AR & RM processes
Maintain trackers, SharePoint & documentation systems
Adhere to Good Documentation Practices (GDocP)

🎓 Eligibility & Qualifications

B.Pharm / M.Pharm / Pharm.D
BSc / MSc – Life Sciences
Experience in Pharmacovigilance / Aggregate Reporting / Risk Management
Strong understanding of global PV regulations (ICH, GVP, FDA, EMA)
Experience with safety databases & reporting tools
Strong documentation & compliance orientation

💼 Salary & Career Benefits

Estimated Salary: ₹6,00,000 – ₹10,00,000 per annum
Exposure to global PV programs
EU QPPV Office collaboration
Automation & AI-driven safety systems
Career growth in Risk Management & Drug Safety
Innovation-driven inclusive culture

📌 Note Before You Apply:
We use a 15-second timer to encourage candidates to carefully review the job description before applying. Ensure your experience aligns with Aggregate Reporting, PSUR/PBRER, and Risk Management activities.

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