PHARMAFull-time
Pharmacovigilance Operations Manager
HYDERABAD (IN)ONSITEPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
ICSR & Case Processing Oversight: Oversee end-to-end Individual Case Safety Report (ICSR) processing workflows, adverse event intake, triaging, review, and expedited regulatory submissions to ensure global compliance across health authorities worldwide.
Vendor & Partner Management: Direct day-to-day operations of pharmacovigilance vendors; lead vendor onboarding, training, resource allocation, and regular management governance meetings; manage safety data exchange agreements (SDEAs) and business partner reconciliation.
Quality Control & Trend Analysis: Perform case quality reviews, analyze Quality Control (QC) trend findings, author comprehensive QC reports, and oversee corrective and preventive actions (CAPAs) to ensure continuous quality improvement.
Regulatory Compliance & QPPV Delegation: Execute specialized tasks delegated by the Qualified Person for Pharmacovigilance (QPPV) as documented in the Pharmacovigilance System Master File (PSMF); maintain continuous inspection readiness.
Audit & Health Authority Inspection Defense: Serve as the primary point of contact and operational representative for internal quality audits and global Health Authority inspections (e.g., FDA, EMA, MHRA).
Team Leadership & Operational Metrics: Allocate and track task assignments across case management direct and indirect reports, establish operational KPIs, and generate compliance, volume, and turnaround time reports.
Technical & Domain Standards
Comprehensive mastery of global pharmacovigilance regulations, GVP guidelines, ICH guidelines (E2A, E2B, E2C), and safety database systems.
Deep experience with safety data exchange agreements, partner reconciliations, and regulatory submission timelines.
Benefits & Organizational Culture
High-impact leadership opportunity within Amgen's global safety operations.
Competitive executive compensation package, performance incentives, and comprehensive corporate healthcare and wellness benefits.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
Vendor Management
Safety Operations
Quality Control (QC)
CAPA
PSMF
QPPV Delegation
Regulatory Inspections
Safety Data Exchange Agreements (SDEA)
Case Management
COMPENSATION & REWARDS
₹14.0L - 24.0L per annum
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/5
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