Pharmacovigilance Operations Manager – Hyderabad, India
Company: Confidential / Leading Biopharmaceutical Organization
Location: Hyderabad, India (On-Site)
Employment Type: Full-Time, Permanent
Job ID: R-232968
Category: Pharmacovigilance / Drug Safety / PV Operations
Posted: 22 December 2025
About the Role
We are seeking a highly skilled Pharmacovigilance Operations Manager to support global safety systems, data analytics, and regulatory reporting in compliance with global pharmacovigilance standards. This role combines leadership, technical expertise, and process management to ensure accurate, timely, and compliant safety data outputs. The position involves driving system improvements, automation, AI adoption, and innovative solutions within the pharmacovigilance environment while maintaining inspection readiness.
The ideal candidate will have extensive experience with PV systems, safety data analytics, and regulatory reporting within pharmaceutical or biotechnology organizations.
Key Responsibilities
Global Safety System & Data Management
Support implementation and configuration of global safety systems and associated data marts
Ensure data integrity, consistency, and reliability for analytics and regulatory reporting
Assist with User Acceptance Testing (UAT), system changes, and validation activities
Collaborate with IT, Data Science, and Managed Services teams to optimize system performance and support
Safety Data Outputs & Regulatory Reporting
Analyze, prioritize, and deliver routine and ad hoc safety data outputs
Generate reports for PSUR, PADER, DSUR, signal detection, audits, and regulatory inquiries
Conduct quality checks and peer reviews for all safety data outputs
Configure reporting tools, including QBE, Cognos, Spotfire, and Tableau, to ensure consistent outputs
Study & Integration Support
Support study start-up activities including EDC mapping (RAVE/Veeva), safety database mapping (LSMV/Argus), and MSW review
Assist with UAT execution, documentation, and reconciliation activities
Automation, AI & Innovation
Identify opportunities to leverage AI, automation, and advanced analytics to improve safety operations
Contribute to evaluation, implementation, and validation of innovative technologies (e.g., AI-assisted case processing, reporting automation)
Ensure regulatory compliance and inspection readiness when piloting innovative solutions
Training & Process Development
Develop and deliver training for safety databases, reporting tools, and PV processes
Support creation and maintenance of SOPs, work instructions, and user manuals
Compliance & Inspection Readiness
Maintain inspection readiness and support regulatory audits and health authority inspections
Act as point of contact for audit responses, internal process reviews, and system compliance initiatives
Knowledge, Skills & Expertise
Technical & Functional Skills
Expertise with PV safety systems (preferably ArisGlobal LifeSphere)
Experience with analytics and reporting tools: Cognos, Spotfire, Tableau
Knowledge of Oracle databases, PL/SQL, and Python scripting
Understanding of data warehouse concepts, data mining, and SDLC processes
Regulatory & Domain Knowledge
Strong understanding of global pharmacovigilance regulations, safety reporting, and clinical trial processes
Familiarity with aggregate safety data analysis and statistical interpretation
Experience supporting audits and regulatory inspections
Professional & Leadership Skills
Excellent organizational, planning, and prioritization skills
Ability to manage multiple deliverables independently
Strong problem-solving, communication, and stakeholder management skills
Proven leadership and team collaboration capabilities
Experience & Education
Experience Requirements:
Pharmaceutical or biotechnology industry experience required
Prior experience in PV systems, safety data analytics, or regulatory reporting preferred
Case management experience is advantageous
Education Requirements:
Master’s degree OR
Bachelor’s degree + 2 years relevant experience OR
Associate’s degree + 6 years relevant experience OR
High school diploma / GED + 8 years relevant experience
Why Join Us
Play a critical role in global pharmacovigilance operations and inspection readiness
Drive innovation and automation within a leading biopharmaceutical organization
Collaborate with cross-functional global teams and enhance regulatory compliance
Access professional growth opportunities in pharmacovigilance, safety analytics, and PV operations
Equal Opportunity Statement
This organization is committed to diversity, equity, and inclusion. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.
Apply Now
Advance your career as a Pharmacovigilance Operations Manager in Hyderabad and contribute to global safety operations, AI-driven innovations, and regulatory excellence in pharmacovigilance.
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