Pharmacovigilance Operations Manager
Location: Hyderabad, India
Work Location Type: On-site
Job ID: R-232968
Category: Drug Safety / Pharmacovigilance
Date Posted: December 22, 2025
Role Overview
The Pharmacovigilance Operations Manager plays a critical role in supporting and optimizing the global pharmacovigilance safety system and associated data mart. This position is responsible for ensuring accurate, compliant, and timely safety data analytics and regulatory reporting, while advancing the responsible use of automation, artificial intelligence (AI), and innovative technologies within the pharmacovigilance ecosystem.
Operating with limited supervision from senior leadership, this role contributes significantly to regulatory compliance, inspection readiness, data integrity, and system governance, while partnering cross-functionally with Safety Technology, IT, Compliance, and PV Operations teams.
Key Responsibilities
Global Safety System & Data Management
Support enhancements, configurations, and maintenance of the global safety system and safety data mart.
Implement system configurations including product setup, study setup, and reporting rules.
Ensure data integrity, consistency, and reliability for all safety analytics and outputs.
Support technical solutions that enable safety system functionality and reporting capabilities.
Participate in and support User Acceptance Testing (UAT) for system changes.
Collaborate with Safety Technology teams and Managed Services partners to optimize system performance.
Safety Data Outputs & Regulatory Reporting
Triage, analyze, prioritize, and fulfill requests for safety data outputs and analytics.
Generate safety data outputs supporting:
Periodic safety reports (PADER, PSUR, DSUR)
Signal detection and benefit–risk evaluations
Audits, inspections, and regulatory authority inquiries
Ensure timely delivery of scheduled and automated safety reports.
Perform quality checks and peer reviews on safety data outputs.
Configure safety systems for routine reporting, including:
Development of user-defined reports
Creation of Query By Example (QBE)
Definition and validation of search strategies in collaboration with functional leads
Participate in business requirement gathering for routine and ad hoc safety reporting.
Study Start-Up & System Integration
Support clinical study start-up and integration activities, including:
EDC (RAVE/Veeva) to safety database (LSMV/Argus) mappings
Mapping Specifications Worksheet (MSW) review and approval
UAT execution and documentation
Automation, AI & Innovation
Identify and support opportunities to leverage AI, automation, and advanced analytics to enhance safety data quality, efficiency, and insight generation.
Contribute to the evaluation, validation, and implementation of innovative solutions such as:
AI-assisted case processing
Signal detection tools
Automated safety reporting solutions
Partner with cross-functional stakeholders to operationalize innovation while maintaining regulatory compliance, data integrity, and inspection readiness.
Stay current on industry trends, regulatory expectations, and emerging technologies related to AI in pharmacovigilance.
Support governance, documentation, and change management for AI-enabled systems.
Training, Documentation & Process Development
Develop and deliver training for safety databases, reporting tools, and PV processes.
Support the creation and maintenance of SOPs, work instructions, system documentation, and user manuals.
Compliance & Inspection Readiness
Perform activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as documented in the PV System Master File.
Maintain a continuous state of inspection readiness.
Serve as a key representative during:
Health Authority inspections
Internal audits
Audit response activities within role scope
Education & Experience Requirements
Education (any one of the following):
Master’s degree
Bachelor’s degree with 2+ years of directly related experience
Associate’s degree with 6+ years of directly related experience
High school diploma / GED with 8+ years of directly related experience
Required Experience:
Pharmaceutical industry and/or health authority experience is required.
Prior experience supporting pharmacovigilance systems, safety data analytics, or regulatory reporting is strongly preferred.
Case management experience is highly desirable.
Experience supporting regulatory inspections or internal audits is an advantage.
Technical & Functional Skills
Strong knowledge of pharmacovigilance safety systems, preferably ArisGlobal LifeSphere.
Experience with safety reporting and analytics tools such as Cognos, Spotfire, or Tableau.
Working knowledge of Oracle databases, Oracle Developer, and programming languages (e.g., Python, PL/SQL).
Understanding of data warehousing, data mining, SDLC, and system validation methodologies.
Solid understanding of global PV regulations and safety reporting requirements.
Knowledge of clinical trial and pharmacovigilance processes.
Familiarity with aggregate safety data analysis and interpretation.
Professional Competencies
Strong organizational, prioritization, and planning skills.
Ability to manage deliverables independently with minimal supervision.
Proactive problem-solving and risk identification capabilities.
Excellent written and verbal communication skills.
Proven ability to collaborate across global, cross-functional teams.
Demonstrated leadership and stakeholder management skills.
Why This Role Matters
This role is central to ensuring robust pharmacovigilance operations, regulatory compliance, and data-driven safety decision-making, while enabling innovation through AI and automation in a highly regulated global environment.
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