Pharmacovigilance Operations Senior Manager
Amgen · Hyderabad
Career Category
SafetyJob Description
The Pharmacovigilance Operations Senior Manager provides strategic leadership and operational oversight of the global safety system and associated data mart to ensure accurate, compliant, and timely safety data analytics and reporting. This role is accountable for driving system performance, data integrity, inspection readiness, and regulatory compliance while advancing adoption of automation, artificial intelligence (AI), and innovative technologies across the pharmacovigilance ecosystem. Operating with a high degree of autonomy, the Senior Manager partners closely with Pharmacovigilance stakeholders to deliver scalable, future-ready solutions that enhance efficiency, insight generation, and regulatory confidence.
Key Responsibilities
Global Safety Systems & Data Governance
- Provide leadership and oversight for changes, enhancements, and configurations of the global safety system and associated data mart.
- Own data integrity, consistency, and reliability standards for safety data used in analytics, regulatory submissions, and decision-making.
- Oversee system configurations, including reporting rules, product and study setup, and integration points.
- Direct and govern User Acceptance Testing (UAT) activities to ensure validated, inspection-ready system changes.
- Partner with Safety Technology and Managed Services to optimize system performance, support models, and service delivery.
Safety Data Outputs & Regulatory Reporting
- Own the strategy, prioritization and delivery of safety data outputs supporting: Periodic safety reporting (e.g., PADER, PSUR, DSUR), Signal detection and safety surveillance & Regulatory inquiries, audits, and inspections
- Ensure timely, high-quality delivery of automated and scheduled safety reports.
- Establish quality oversight, peer review standards, and continuous improvement for safety data outputs.
- Lead the definition and implementation of reporting solutions, including: User-defined reports, Query By Example (QBE) & Optimized search strategies aligned with global standards
- Translate business requirements into scalable, compliant reporting solutions.
Study Start-Up & Systems Integration
Provide strategic oversight for study start-up and integration activities, including:
- EDC–Safety Database integrations (e.g., RAVE/Veeva to LSMV/Argus)
- Review and approval of Mapping Specifications Worksheets (MSWs)
- UAT planning, execution, and documentation
- Ensure integrations meet regulatory, validation, and data quality expectations.
Automation, AI & Innovation Leadership
- Define and drive the roadmap for automation, AI, and advanced analytics within pharmacovigilance operations.
- Lead the evaluation, implementation, and validation of innovative technologies, including: AI-assisted case processing, Signal detection and analytics solutions & Reporting and workflow automation
- Partner cross-functionally to pilot and operationalize new capabilities while ensuring compliance, data integrity, and inspection readiness.
- Monitor emerging technologies, industry trends, and regulatory expectations related to AI in pharmacovigilance.
- Establish governance, documentation, and change management frameworks to ensure sustainable and compliant adoption of innovation.
Training, Process Excellence & Capability Building
- Lead the development and delivery of training for safety systems, reporting tools, and associated processes.
- Drive process standardization and continuous improvement through SOPs, work instructions and user documentation.
- Mentor and develop team members, strengthening technical depth and leadership capability.
Compliance & Inspection Readiness
- Execute activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as defined in the PV System Master File.
- Maintain a continuous state of inspection readiness across systems, data, and processes.
- Serve as a primary representative for: Health Authority inspections, Internal and external audits
- Own audit responses and remediation activities within scope of responsibility.
Knowledge, Skills, and Experience
Technical & Functional Expertise
- Deep expertise in pharmacovigilance safety systems, preferably ArisGlobal LifeSphere.
- Strong experience with reporting and analytics platforms (e.g., Cognos, Spotfire, Tableau).
- Working knowledge of Oracle databases, Oracle Developer, and programming languages (e.g., Python, PL/SQL).
- Solid understanding of data warehousing, analytics, and data mining techniques.
- Proven experience with SDLC, system validation, and regulated development standards.
Regulatory & Domain Expertise
- Strong understanding of global pharmacovigilance regulations and safety reporting requirements.
- In-depth knowledge of clinical trial and pharmacovigilance operational processes.
- Experience supporting regulatory inspections and internal audits in a leadership capacity.
- Ability to interpret and apply aggregate safety data and analytics to regulatory and business decisions.
Leadership & Professional Skills
- Proven ability to lead complex, cross-functional initiatives with minimal oversight.
- Strong strategic thinking, prioritization, and execution skills.
- Decisive problem-solver with sound judgment and escalation instincts.
- Executive-level written and verbal communication skills.
- Demonstrated ability to influence, build partnerships, and lead through change.
Experience
- Pharmaceutical industry and/or health authority experience required.
- Prior experience supporting pharmacovigilance systems, safety data analytics, or regulatory reporting strongly preferred.
- Case management experience is strongly preferred.
Education
- Doctorate degree OR
- Master’s degree and 3 years of directly related experience OR
- Bachelor’s degree and 5 years of directly related experience OR
- Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience