Novartis Hiring Aggregate Reports Risk Management Analyst Jobs in Hyderabad for pharmacovigilance and safety science professionals.
Company Overview
Novartis is a globally respected healthcare organization committed to reimagining medicine through innovation, science, and digital transformation. With a strong presence in drug development, patient safety, and pharmacovigilance, Novartis supports regulatory-compliant lifecycle management of medicines across global markets.
The Aggregate Reports & Risk Management (AR&RM) function plays a critical role within Patient Safety & Pharmacovigilance (PS&PV), ensuring timely preparation, quality oversight, compliance, and inspection readiness of regulatory safety documents. This position offers hands-on exposure to global safety reporting, audits, compliance tracking, and advanced automation initiatives. Novartis Hiring Aggregate Reports Risk
Job Location & Employment Type
- Job Location: Hyderabad, Telangana, India (Office-based)
- Employment Type: Full-Time
- Job Type: Permanent
- Functional Area: Pharmacovigilance / Safety Science / Risk Management
Open Positions / Department Details
- Job Title: Aggregate Reports & Risk Management Analyst
- Department: Patient Safety & Pharmacovigilance (PS&PV)
- Job Requisition ID: REQ-10071108
This role supports development portfolio products and contributes to global aggregate reporting and risk management operations. Novartis Hiring Aggregate Reports Risk
Key Roles & Responsibilities
The selected professional will support end-to-end operations of aggregate reporting and risk management deliverables. Major responsibilities include: Novartis Hiring Aggregate Reports Risk
- Assisting in the preparation of assigned aggregate safety and risk management reports in line with internal and regulatory requirements
- Retrieving, validating, and organizing safety data from global pharmacovigilance databases as per company SOPs
- Supporting quality control (QC) reviews of aggregate reports to ensure data accuracy, consistency, and regulatory compliance
- Managing scheduling and tracking of AR&RM deliverables to meet regulatory timelines
- Supporting project activities led by Patient Safety & Pharmacovigilance teams
- Coordinating with licensing partners to ensure joint reporting responsibilities are fulfilled
- Assisting in root cause analysis (RCA), corrective and preventive actions (CAPA), and quality incident management
- Supporting inspection and audit readiness through proper documentation, archiving, and tracking of ongoing activities
- Collaborating on automation initiatives, including implementation and testing of safety systems and IT applications
- Coordinating the collection, distribution, and archival of essential documents such as certificates and signed cover pages
- Managing inbound and outbound communications through AR&RM mailboxes
- Coordinating publication, submission, and dispatch of assigned aggregate reports
- Acting as a super user for AR&RM tools and systems used in report preparation and finalization
- Collecting data and preparing metrics for dashboards, governance boards, and compliance reviews
- Maintaining Health Authority AR&RM trackers to ensure timely incorporation of regulatory feedback
- Managing and guiding usage of tracking tools, SharePoint platforms, and shared drives
- Supporting operational excellence initiatives, including adoption of Artificial Intelligence and advanced digital tools
- Assisting in preparation of AR&RM compliance reports for senior leadership and EU QPPV Office
- Preparing documentation contributing to regulatory files such as the Pharmacovigilance System Master File (PSMF)
- Supporting ongoing tracking of safety and quality metrics within PS&PV
- Training and onboarding new team members on assigned AR&RM processes
- Adhering to good documentation practices to maintain continuous audit and inspection readiness
- Performing administrative and coordination activities required to support AR&RM operations
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in:
- Pharmacy
- Life Sciences
- Biotechnology
- Related healthcare or scientific disciplines
Experience
- Prior experience or exposure to pharmacovigilance, aggregate reporting, safety science, or regulatory operations is desirable
- Candidates with experience in databases, reporting, or compliance tracking will be preferred
Skills Required
- Understanding of pharmacovigilance and aggregate safety reporting concepts
- Familiarity with global safety databases and regulatory documentation
- Strong documentation and data tracking skills
- Ability to manage multiple deliverables within defined timelines
- Good project coordination and organizational abilities
- Strong written and verbal communication skills
- Comfort with metrics preparation, reporting dashboards, and compliance tracking
- Proficiency in handling documentation systems, shared drives, and digital collaboration tools
- Willingness to learn automation, AI-based tools, and advanced safety systems
Novartis Hiring Aggregate Reports Risk
Salary & Benefits
- Salary: As per company norms
- Comprehensive benefits aligned with Novartis India policies and global standards
Selection Process
The selection process may include:
- Profile screening
- Technical or functional interview
- HR discussion
Final selection will depend on skills, experience, and business requirements.
How to Apply
- Application Mode: Online application only
- Candidates must apply through the official Novartis careers portal using the requisition ID
No walk-in or email application process is specified. Novartis Hiring Aggregate Reports Risk
Important Dates
- Application Deadline: 31 March 2026
Early application is recommended due to the global scope of the role. Novartis Hiring Aggregate Reports Risk
Why Apply for This Pharma Job?
- Work with a top global pharmaceutical organization
- Exposure to international aggregate safety reporting and risk management
- Strong learning environment within Patient Safety & Pharmacovigilance
- Opportunity to contribute to regulatory compliance and inspection readiness
- Involvement in automation, AI, and digital transformation initiatives
- Long-term career growth in safety science and regulatory operations
Novartis Hiring Aggregate Reports Risk
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Novartis or its subsidiaries. Job details are shared strictly for informational purposes. Candidates should verify all information on the official company website before applying. Novartis Hiring Aggregate Reports Risk
Final Call-to-Action
If you are looking to build a career in aggregate safety reporting and risk management within a global pharmacovigilance environment, apply online for this role before the deadline. Novartis Hiring Aggregate Reports Risk
