Novartis Hiring Pharmacovigilance Aggregate Reports & Risk Management Analyst
- Novartis Hiring Aggregate Reports & Risk Management Analyst – Hyderabad (Full-Time, R&D Division)
- Company Overview
- Job Role & Responsibilities
- Aggregate Report Preparation & QC Support
- Risk Management & Compliance Tracking
- RCA, CAPA & Quality Incident Support
- Audit & Inspection Readiness
- Project & Operational Excellence Support
- Documentation & Administrative Coordination
- Key Performance Indicators (KPIs)
- Eligibility / Qualifications
- Preferred Educational Background
- Experience Requirements
- Technical & Functional Skills
- Location & Employment Details
- Application Process
- Why Consider This Role?
- Frequently Asked Questions (FAQs)
- Summary Table
Novartis Hiring Aggregate Reports & Risk Management Analyst – Hyderabad (Full-Time, R&D Division)
Novartis Healthcare Private Limited is hiring for the position of Aggregate Reports & Risk Management (AR&RM) Analyst under its Development – Research & Development (R&D) division in Hyderabad, India. This is a full-time, regular role focused on pharmacovigilance operations, aggregate safety reporting, compliance tracking, audit readiness, and regulatory documentation support. The position plays a critical role in supporting global drug safety deliverables and risk management processes across the product portfolio.
This opportunity is ideal for professionals seeking careers in pharmacovigilance, aggregate safety reporting, regulatory compliance, drug safety analytics, and global risk management within a multinational pharmaceutical organization.
Company Overview
Novartis is a global healthcare company committed to reimagining medicine and improving patient outcomes worldwide. With a strong presence in innovative medicines and development programs, Novartis operates across research, clinical development, regulatory strategy, and global safety monitoring.
Within the Development function, the Patient Safety & Pharmacovigilance (PS&PV) organization ensures that safety data is monitored, evaluated, and reported in compliance with global health authority requirements including FDA, EMA, and other international regulators. The Aggregate Reports & Risk Management (AR&RM) team plays a vital role in preparing periodic safety reports, risk management plans, compliance dashboards, and regulatory documentation required for maintaining product approvals.
Working at Novartis provides exposure to global regulatory frameworks, high standards of quality systems, digital transformation initiatives, and structured operational excellence programs.
Job Role & Responsibilities
The AR&RM Analyst will support operational management of aggregate safety reports and risk management deliverables for products within the Development portfolio. The role requires strong coordination, documentation control, compliance monitoring, and data tracking capabilities.
Aggregate Report Preparation & QC Support
- Support preparation of assigned aggregate safety and risk management reports
- Retrieve safety data from global pharmacovigilance databases as per SOPs
- Perform quality control (QC) checks to ensure reports are complete, accurate, and compliant with regulatory templates
- Coordinate publishing and dispatch of finalized reports
Risk Management & Compliance Tracking
- Support scheduling and tracking of AR&RM deliverables
- Maintain Health Authority (HA) trackers for assigned products
- Monitor AR&RM compliance indicators and prepare metrics for management review
- Support preparation of quarterly compliance reports for senior leadership and EU QPPV Office
RCA, CAPA & Quality Incident Support
- Assist in preparation and follow-up of Root Cause Analysis (RCA)
- Support Corrective and Preventive Action (CAPA) documentation
- Maintain proper archival and documentation for inspection readiness
Audit & Inspection Readiness
- Ensure adherence to good documentation practices
- Support internal and external audit preparation activities
- Coordinate archival of ongoing AR&RM documentation
- Maintain regulatory documentation contributing to Pharmacovigilance System Master File (PSMF)
Project & Operational Excellence Support
- Collaborate in automation and digital initiatives including AI-driven process improvements
- Support testing of safety systems and IT applications
- Contribute to operational excellence projects within PS&PV
Documentation & Administrative Coordination
- Handle inbound and outbound AR&RM mailbox communications
- Coordinate collection and distribution of documentation such as certificates and signatures
- Maintain tracking tools, SharePoint systems, and shared drives
- Train and onboard new colleagues in AR&RM processes
This role demands high attention to detail, regulatory awareness, project coordination skills, and structured documentation management.
Key Performance Indicators (KPIs)
- Timely and accurate tracking of safety deliverables
- High-quality documentation practices
- Strong compliance and audit readiness
- Effective support to assigned AR&RM projects
- Consistent performance against regulatory timelines
Eligibility / Qualifications
While the official posting does not explicitly list educational qualifications, roles in aggregate reporting and pharmacovigilance typically require relevant healthcare or life sciences backgrounds.
Preferred Educational Background
B.Pharm, M.Pharm, PharmD, M.Sc Life Sciences, Biotechnology, Pharmacology, Pharmaceutical Sciences, Clinical Research
Experience Requirements
- Experience in pharmacovigilance, aggregate reporting, or regulatory operations preferred
- Knowledge of global safety reporting standards and compliance processes
Technical & Functional Skills
- Understanding of aggregate reports such as PSUR, PBRER, DSUR, RMP
- Familiarity with pharmacovigilance databases and tracking systems
- Strong documentation and compliance knowledge
- Experience with CAPA, RCA, and quality management systems
- Proficiency in Microsoft Office tools and data tracking platforms
- Ability to collaborate across cross-functional global teams
Location & Employment Details
Location: Hyderabad (Office-based)
Division: Development – Research & Development
Employment Type: Full-Time, Regular
Shift Work: No
Compensation will be aligned with industry standards and based on candidate experience and internal compensation policies.
Application Process
Interested candidates can apply directly through the official Novartis careers portal using the link below:
Candidates are encouraged to apply before the closing deadline. Early application is recommended.
Why Consider This Role?
- Exposure to global pharmacovigilance and risk management systems
- Opportunity to work with senior safety leaders and EU QPPV office
- Participation in automation and AI-driven safety initiatives
- Strong career pathway in drug safety, aggregate reporting, and regulatory compliance
- Work within a multinational pharmaceutical R&D environment
Frequently Asked Questions (FAQs)
What does an Aggregate Reports & Risk Management Analyst do?
The role supports preparation, tracking, and compliance management of periodic safety reports and risk management documentation required by global regulators.
Is this a pharmacovigilance role?
Yes. It falls under the Patient Safety & Pharmacovigilance function within R&D.
Where is this job located?
The position is based in Hyderabad, India.
Does the role involve audit support?
Yes. Audit readiness and inspection support are key responsibilities.
Is prior experience required?
Experience in aggregate reporting or regulatory operations is preferred.
Summary Table
| Company | Novartis Healthcare Private Limited |
|---|---|
| Vacancies | Aggregate Reports & Risk Management Analyst |
| Required Education | B.Pharm, M.Pharm, PharmD, M.Sc Life Sciences |
| Experience | Pharmacovigilance / Regulatory Experience Preferred |
To apply for this job please visit www.novartis.com.
