Pharmacovigilance Operations Manager
Location: Hyderabad, India
Work Mode: On-site
Job ID: R-232968
Category: Drug Safety / Pharmacovigilance
Posted On: December 22, 2025
About the Role
The Pharmacovigilance Operations Manager plays a critical role in supporting global safety systems and safety data analytics to ensure accurate, compliant, and timely pharmacovigilance reporting. This position contributes to inspection readiness, regulatory compliance, and continuous improvement of safety system capabilities, including the responsible adoption of automation, artificial intelligence (AI), and innovative technologies.
Operating with limited supervision from senior leadership, the role supports safety system configuration, data integrity, regulatory reporting, and training activities while collaborating closely with Safety Technology, PV Operations, IT, Compliance, and Managed Services teams.
Key Responsibilities
Global Safety Systems & Data Management
Support enhancements, configurations, and maintenance of the global pharmacovigilance safety system and associated data marts.
Configure reporting rules, product hierarchies, and study setups to ensure accurate safety data capture and reporting.
Ensure consistency, integrity, and reliability of safety data used for analytics and regulatory outputs.
Participate in User Acceptance Testing (UAT) activities for safety system changes, including documentation and validation.
Collaborate with Safety Technology teams and Managed Services partners to optimize system performance and support.
Safety Data Outputs & Regulatory Reporting
Triage, prioritize, and fulfill requests for safety data outputs across global stakeholders.
Generate and review safety data outputs supporting periodic safety reports (PADER, PSUR, DSUR), signal detection activities, audits, inspections, and regulatory inquiries.
Deliver automated and scheduled safety reports within defined timelines.
Perform quality checks, peer reviews, and validation of safety data outputs.
Configure and maintain reporting tools, including user-defined reports, Query by Example (QBE), and search strategies aligned with business requirements.
Study & System Integration Support
Support clinical study start-up and integration activities, including:
EDC (RAVE, Veeva) to safety database mapping (Argus, LifeSphere)
Review and approval of Mapping Specifications Worksheets (MSW)
UAT execution, documentation, and validation support
Automation, AI & Innovation
Identify and support opportunities to apply automation, AI, and advanced analytics to improve pharmacovigilance data quality and operational efficiency.
Contribute to the evaluation, validation, and implementation of innovative solutions such as AI-assisted case processing, automated reporting, and signal detection tools.
Partner with cross-functional stakeholders to pilot and operationalize innovative technologies while ensuring regulatory compliance and inspection readiness.
Monitor emerging industry trends, regulatory expectations, and best practices related to AI and advanced analytics in pharmacovigilance.
Support governance, documentation, change management, and compliance activities related to technology-enabled solutions.
Training, Process & Compliance Support
Develop and deliver training for pharmacovigilance systems, reporting tools, and related processes.
Contribute to the development and maintenance of SOPs, work instructions, and user documentation.
Perform delegated activities under the Qualified Person for Pharmacovigilance (QPPV), as outlined in the Pharmacovigilance System Master File (PSMF).
Maintain a continuous state of inspection readiness and act as a point of contact during health authority inspections and internal audits.
Support audit preparation, responses, and corrective actions within the scope of responsibility.
Required Qualifications & Experience
Education
Master’s degree, OR
Bachelor’s degree with 2+ years of directly related experience, OR
Associate degree with 6+ years of directly related experience, OR
High school diploma / GED with 8+ years of directly related experience
Professional Experience
Required experience within the pharmaceutical industry and/or a health authority environment.
Prior experience supporting pharmacovigilance systems, safety data analytics, or regulatory safety reporting strongly preferred.
Case management experience in a pharmacovigilance setting is highly desirable.
Technical & Functional Skills
Strong knowledge of pharmacovigilance safety systems; experience with ArisGlobal LifeSphere preferred.
Experience with reporting and analytics tools such as Cognos, Spotfire, and Tableau.
Working knowledge of Oracle databases, Oracle Developer, and programming languages such as Python and PL/SQL.
Understanding of data warehouse concepts, data mining techniques, and SDLC/validation methodologies.
Regulatory & Domain Knowledge
Solid understanding of global pharmacovigilance regulations and safety reporting requirements.
Knowledge of clinical trial and pharmacovigilance operational processes.
Experience supporting regulatory inspections and internal audits.
Familiarity with aggregate safety data analysis and interpretation.
Core Competencies
Strong organizational and prioritization skills
Independent delivery with minimal supervision
Proactive problem-solving and risk escalation
Excellent written and verbal communication skills
Cross-functional collaboration and stakeholder management
Demonstrated leadership and accountability
Why Join Amgen
Amgen offers a collaborative, innovation-driven environment where employees contribute directly to patient safety and regulatory excellence. The organization supports professional development, global exposure, and competitive total rewards aligned with local market standards.
Apply Now
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