PHARMAFull-time
Sr Assoc Pharmacovigilance Operations
HYDERABAD (IN)ONSITEPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
ICSR Review & Expedited Reporting: Perform comprehensive medical/technical review of Individual Case Safety Reports (ICSRs), evaluate reportability criteria, and execute regulatory reporting decisions for expedited submissions to global health authorities (FDA, EMA) and business partners within strict statutory timelines.
Vendor Oversight & Operational Support: Support vendor oversight across adverse event (AE) intake, triage, and data entry workflows; resolve complex intake and processing queries; escalate case-level data quality discrepancies.
Safety Reconciliation & Literature Review: Execute Business Partner (BP) safety reconciliations in line with Safety Data Exchange Agreements (SDEAs), perform reportable event reconciliation for Amgen-sponsored clinical trials, and assist in literature screening for ICSR identification.
E2B & Technical Operations: Provide Local Affiliate Office (LAO) E2B support including nullifications, amendments, and redistributions; coordinate unblinding requests when required.
Audit Readiness & QPPV Tasks: Undertake delegated QPPV activities as outlined in the Pharmacovigilance System Master File (PSMF) and support internal quality audits and Health Authority inspections.
Technical & Domain Standards
Strong understanding of global PV regulations, GVP guidelines, ICH E2A/E2B/E2C reporting standards, and safety database operations.
Meticulous attention to detail, case processing quality metrics, and regulatory compliance timelines.
Benefits & Total Rewards
Opportunity to work within Amgen's global safety organization supporting critical therapeutics.
Competitive compensation structure, performance bonuses, comprehensive medical coverage, and structured professional development pathways.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
Adverse Event Intake
Safety Reporting
FDA/EMA Guidelines
ICH-GCP
E2B Transmission
Vendor Oversight
Safety Reconciliation
PSMF
COMPENSATION & REWARDS
₹6.5L - 11.0L 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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