Pharmacovigilance Operations Senior Manager

Amgen; Hyderabad; On-site; INR 3,000,000 - 4,200,000; Full time

Job summary

Amgen seeks a Pharmacovigilance Operations Senior Manager to provide strategic leadership and oversight of global safety systems and data analytics. You will drive data integrity, regulatory reporting readiness, and scalable solutions while advancing automation, AI, and innovative technologies across pharmacovigilance.

You will lead study start-up, system integration, and quality improvements with a focus on inspection readiness and cross-functional collaboration in a dynamic, global setting.

Qualifications

• Advanced expertise in pharmacovigilance safety systems and data governance.
• Experience leading global safety data analytics, reporting and system validation.
• Proven ability to deliver inspection-ready, compliant solutions at scale.

Responsibilities

• Lead changes and configurations of global safety systems and data marts.
• Oversee data integrity for analytics, regulatory submissions and decision-making.
• Direct UAT and partner with Safety Tech to optimize performance and delivery.
• Define reporting solutions including UDRs, QBE and optimized search strategies.
• Drive automation, AI and innovation while maintaining compliance and inspection readiness.

Skills

Pharmacovigilance

Data governance

System integration

Regulatory reporting

Executive communication

Education

Doctorate degree

Master's degree

Bachelor's degree

Tools

ArisGlobal LifeSphere

Cognos

Spotfire

Tableau

Oracle SQL

Python

PL/SQL

Job description

Career Category Safety Job 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.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen