Title: Pharmacovigilance Operations Senior Manager
Location: Hyderabad, India
Category: Safety & Pharmacovigilance
Job Type: Full-Time
Company Overview:
Join a global leader in healthcare and pharmaceuticals, driving innovation, compliance, and patient safety across the drug development lifecycle. Our pharmacovigilance operations ensure accurate, timely, and regulatory-compliant safety data management, supporting both clinical and post-marketing activities worldwide.
Role Overview:
The Pharmacovigilance Operations Senior Manager provides strategic leadership and operational oversight of global safety systems and associated data marts. This role is responsible for ensuring data integrity, inspection readiness, and regulatory compliance while advancing automation, AI, and innovative technologies within pharmacovigilance operations. Operating with high autonomy, the Senior Manager collaborates with global stakeholders to deliver scalable, future-ready solutions that enhance efficiency, data insights, and regulatory confidence.
Key Responsibilities:
Global Safety Systems & Data Governance:
Lead changes, enhancements, and configurations of global pharmacovigilance systems and data marts.
Ensure data integrity, consistency, and reliability for regulatory submissions and analytics.
Oversee system configurations, integrations, reporting rules, and validation activities.
Govern User Acceptance Testing (UAT) to maintain inspection-ready systems.
Partner with Safety Technology and Managed Services to optimize system performance.
Safety Data Outputs & Regulatory Reporting:
Own the strategy and delivery of safety data outputs, including PSUR, DSUR, PADER, signal detection, and regulatory inquiries.
Ensure timely, high-quality delivery of automated and scheduled safety reports.
Implement peer review, quality oversight, and continuous improvement for all safety data outputs.
Develop and optimize reporting solutions aligned with global regulatory standards.
Study Start-Up & Systems Integration:
Provide strategic oversight for study start-up, system setup, and integration (e.g., EDC to Safety Database).
Review and approve Mapping Specification Worksheets (MSWs).
Ensure integration activities meet regulatory, validation, and data quality standards.
Automation, AI & Innovation Leadership:
Define and execute the roadmap for AI, automation, and advanced analytics in pharmacovigilance operations.
Lead evaluation, validation, and operationalization of AI-assisted case processing, signal detection, and workflow automation tools.
Monitor emerging technologies and regulatory expectations to drive innovative solutions.
Training, Process Excellence & Capability Building:
Develop and deliver training on safety systems, reporting tools, and associated processes.
Drive SOP standardization, process improvement, and knowledge sharing.
Mentor and develop team members, enhancing technical and leadership capabilities.
Compliance & Inspection Readiness:
Execute activities delegated by the Qualified Person for Pharmacovigilance (QPPV).
Maintain continuous inspection readiness across systems, data, and processes.
Represent the organization during Health Authority inspections, internal and external audits.
Oversee audit responses and remediation activities within scope of responsibility.
Required Skills & Experience:
Technical & Functional Expertise:
Deep expertise in pharmacovigilance systems, preferably ArisGlobal LifeSphere.
Strong experience with reporting/analytics platforms (e.g., Cognos, Spotfire, Tableau).
Knowledge of Oracle databases, programming languages (Python, PL/SQL), data warehousing, and analytics.
Familiarity with SDLC, system validation, and regulated development standards.
Regulatory & Domain Expertise:
Strong understanding of global pharmacovigilance regulations and safety reporting requirements.
Experience in clinical trial and PV operational processes.
Demonstrated ability to interpret aggregate safety data for regulatory and business decisions.
Prior involvement in inspections and audits is highly desired.
Leadership & Professional Skills:
Proven ability to lead complex, cross-functional initiatives independently.
Strategic thinking, prioritization, and decisive problem-solving skills.
Executive-level communication, collaboration, and influence abilities.
Experience driving innovation and change within PV operations.
Education & Experience:
Doctorate degree OR
Master’s degree + 3 years relevant experience OR
Bachelor’s degree + 5 years relevant experience OR
Associate degree + 10 years relevant experience OR
High school diploma/GED + 12 years relevant experience
Apply Now: Lead global pharmacovigilance operations and innovation as a Senior Manager in Hyderabad, India.
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