Pharmacovigilance Operations Manager
Location: Hyderabad, India
Employment Type: Full-Time, On-Site
Job ID: R-232968
About the Role
The Pharmacovigilance Operations Manager plays a critical role in ensuring accurate, compliant, and timely pharmacovigilance operations within a global safety system. This position supports safety system configurations, data integrity, regulatory reporting, and advanced automation initiatives, including AI-driven solutions.
The role requires collaboration with cross-functional teams, inspection readiness, and a focus on process innovation to enhance safety data quality, efficiency, and insight generation.
Key Responsibilities
Global Safety System & Data Support
Support changes and configurations in global safety systems and associated data marts.
Maintain data integrity, consistency, and reliability for analytics and reporting.
Participate in User Acceptance Testing (UAT) for system changes and optimizations.
Partner with Safety Technology and Managed Services teams to optimize system functionality.
Safety Data Outputs & Regulatory Reporting
Generate and review safety data outputs for PADER, PSUR, DSUR, signal detection, audits, and regulatory inquiries.
Perform quality checks and peer reviews of safety data outputs.
Develop and configure user reports, Query By Example (QBE), and search strategies for reliable outputs.
Study & Integration Support
Support study start-up activities, including mapping EDC systems (RAVE/Veeva) to safety databases (LSMV/Argus).
Review Mapping Specifications Worksheets (MSW) and execute UAT documentation.
Automation & Innovation
Identify opportunities to leverage AI, automation, and advanced analytics in pharmacovigilance.
Support evaluation, implementation, and validation of AI-assisted case processing, signal detection, and reporting automation.
Partner with IT, Data Science, PV Operations, and Compliance teams to operationalize innovative solutions.
Stay updated on emerging technologies, industry trends, and regulatory expectations related to AI and advanced analytics in PV.
Training & Process Development
Develop and deliver training for safety databases, reporting tools, and processes.
Assist in the creation and maintenance of SOPs, work instructions, and user manuals.
Compliance & Inspection Readiness
Support activities delegated by the Qualified Person for Pharmacovigilance (QPPV).
Ensure continuous inspection readiness and serve as a point of contact for health authority inspections, internal audits, and audit responses.
Knowledge, Skills & Experience
Technical & Functional Expertise
Strong knowledge of pharmacovigilance safety systems (preferably ArisGlobal LifeSphere).
Proficiency in reporting and analytics tools such as Cognos, Spotfire, Tableau.
Working knowledge of Oracle databases, Oracle Developer, Python, PL/SQL.
Understanding of data warehouse concepts, data mining, SDLC, validation methodologies, and development standards.
Regulatory & Domain Knowledge
Solid understanding of global PV regulations, safety reporting, and clinical trial processes.
Familiarity with aggregate safety data analysis.
Experience supporting regulatory inspections or internal audits.
Professional Skills
Strong organization, prioritization, and planning skills.
Ability to work independently and proactively.
Excellent written and verbal communication skills.
Strong cross-functional collaboration and leadership capabilities.
Experience
Pharmaceutical industry and/or health authority experience required.
Prior experience in PV systems, safety data analytics, regulatory reporting, and case management preferred.
Education Requirements
Master’s degree OR
Bachelor’s degree + 2 years of relevant experience OR
Associate’s degree + 6 years of relevant experience OR
High school diploma / GED + 8 years of relevant experience
Why Join
Lead cutting-edge pharmacovigilance operations in a global pharmaceutical environment.
Work with AI and automation technologies to optimize safety and regulatory reporting.
Be part of a dynamic, inspection-ready team ensuring compliance with global PV regulations.
Opportunities for professional growth, cross-functional collaboration, and leadership development.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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