Vigilance Process Manager
REQ-10059927
Hyderabad, India
Site: Hyderabad (Office)
Division: Development
Business Unit: Innovative Medicines
Company / Legal Entity: IN10 (Novartis Healthcare Private Limited)
Functional Area: Research & Development
Job Type: Full-time | Regular
Shift Work: No
Date Posted: August 17, 2025
The Vigilance Process Manager is responsible for end-to-end management of assigned pharmacovigilance and device vigilance processes across Novartis. This includes leading cross-functional projects, driving process improvements, and ensuring full compliance with global regulatory requirements. The role plays a critical part in strategic transformation initiatives, quality oversight, and business continuity for safety operations.
Own and manage assigned vigilance processes and related procedural documents.
Ensure processes are compliant with international regulations and Novartis standards.
Lead impact assessments on emerging regulations and adjust processes accordingly.
Monitor the effect of organizational/process changes across Novartis.
Lead and support cross-functional and PS&PV transformation projects (e.g., automation, IT system changes).
Collaborate with Product Owners to align processes with business goals and regulatory standards.
Drive efficiency and business benefits through process re-engineering.
Develop tools to support quality monitoring and introduce automation where possible.
Ensure regulatory and internal compliance by:
Monitoring KPIs and quality metrics
Implementing mitigation strategies for deviations
Act as SME during internal and external audits/inspections (e.g., FDA, EMA).
Lead preparation of responses and corrective/preventive action plans (CAPAs).
Act as subject matter expert for PS&PV associates, country organizations, and other global functions.
Mentor new associates and lead training initiatives across global teams.
Support cross-divisional collaborations, third-party partnerships, and business continuity planning.
Represent Novartis in external forums and industry networks as a thought leader and subject matter expert.
Full compliance of assigned processes with regulations and internal policies.
Timely and successful implementation of process improvements and projects.
Quality and timeliness of deliverables and regulatory submissions.
Zero critical audit/inspection findings.
Timely risk identification, escalation, and mitigation.
PhD, PharmD, M Pharm, BSc, MSc, BDS/MDS, or equivalent in Life Sciences.
5–8 years in the pharmaceutical industry, specifically in pharmacovigilance.
Proven track record in:
Leading process improvement initiatives
Project management in matrix/global environments
Regulatory inspections and compliance
Process ownership and re-engineering
Familiarity with tools such as ARGUS, Veeva, and relevant PV regulations.
Process Ownership & Compliance
Case Processing & Regulatory Knowledge
Project Leadership & Stakeholder Management
Business Analysis & High Adaptability
Executive Decision-Making
Analytical & Organizational Skills
Quality-Focused Mindset
Strong negotiation, presentation, and communication skills
Ability to mentor, train, and influence cross-functional teams
English (Fluent)
Additional languages are a plus.
At Novartis, we believe that improving lives starts with people. By fostering a culture of curiosity, courage, and collaboration, we empower our associates to tackle healthcare's most challenging problems.
“Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.”
🔗 Explore Novartis People & Culture
Novartis is committed to building an inclusive work environment and creating diverse teams reflective of the communities we serve.
📩 Accessibility & Accommodation:
If you require a reasonable accommodation due to a medical condition or disability, please contact:
diversityandincl.india@novartis.com
(Include job requisition number in your message)
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