Manager – Systems Management
Estimated Salary: ₹25–35 LPA
Location: Hyderabad, India
Position Summary:
The Manager, Systems Management at Novartis plays a critical role in sustaining and enhancing drug safety systems that comply with evolving regulations in Pharmacovigilance and Clinical Safety. This role involves supporting system configuration, data management, audit preparedness, and implementing IT solutions to drive operational excellence in PS&PV (Patient Safety & Pharmacovigilance). The role interfaces across teams to deliver value-added solutions, improve processes, and ensure system integrity.
Key Responsibilities:
Collaborate with the Associate Director to anticipate technology-driven opportunities for Global Development.
Support project proposals and business case definitions, and gather detailed requirements from stakeholders.
Work closely with cross-functional teams to define project scope, goals, and success metrics.
Analyze and model current ("as-is") processes and contribute to the design of future ("to-be") processes.
Prepare data flow analyses and support necessary data conversions or migrations.
Perform system configuration changes, test modifications, and conduct performance qualification testing.
Offer first-line operational and administrative support for safety database users.
Generate and support the creation of specialized reports from PS&PV systems.
Provide mentoring to new team members and lead discussions during audits and inspections.
Maintain documentation for traceability and ensure governance with external vendors.
Qualifications & Experience:
Minimum 7 years’ experience in drug development with expertise in safety database administration.
At least 4 years in safety data management discipline.
Strong knowledge of Oracle, SAS databases, and high proficiency in SQL.
Familiarity with MedDRA and disease dictionaries.
Deep understanding of Drug Safety business processes and IT-business alignment challenges.
Proven project management, mentoring, and leadership capabilities.
Ability to effectively collaborate across internal and external stakeholders.
Skills Required:
Process analysis and improvement
Technical configuration and system validation
Cross-functional collaboration
Data modeling and reporting
Audit and inspection leadership
Communication and stakeholder engagement
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full-Time
Employment Type: Regular
Shift Work: No
Accessibility and Inclusion:
Novartis is committed to equal opportunity employment and provides reasonable accommodations for individuals with disabilities. For accommodation requests, contact: diversityandincl.india@novartis.com
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