Job Title: Senior Associate – Pharmacovigilance Operations
Job ID: R-233379
Location: Hyderabad, India (On-Site)
Job Type: Full-Time
Experience Required: 2–6 years in Pharmacovigilance / Safety Operations
Company Overview
Join a global biopharmaceutical organization dedicated to improving patient safety and advancing therapies worldwide. As part of the Pharmacovigilance (PV) team, you will contribute to ensuring regulatory compliance, timely safety reporting, and operational excellence across clinical and post-marketing studies.
Role Overview
The Senior Associate – Pharmacovigilance Operations acts as the US/EU Local Safety Office (LSO) and the FDA/EMA point of contact for safety reporting. This role supports case processing, vendor oversight, quality monitoring, and audit readiness. You will play a key part in maintaining compliance with global PV regulations and ensuring high-quality Individual Case Safety Reports (ICSRs).
Key Responsibilities
Case Management & Safety Reporting:
Support ICSR intake, triage, data entry, and reconciliation activities for Amgen-sponsored clinical trials.
Evaluate individual ICSRs for reporting in compliance with regulatory requirements (FDA, EMA) and contractual obligations.
Ensure timely submission of expedited safety reports to FDA/EMA and business partners.
Perform US case follow-ups, unblinding, and literature review as required.
Vendor Oversight & Quality Control:
Manage and oversee vendor teams responsible for case intake and processing.
Monitor case quality and report trends in quality measures to management.
Ensure vendor compliance with approved processes, training, and SOPs.
Training & Compliance Support:
Support convention-related training delivery and provide guidance on PV processes.
Assist with audit and inspection readiness, representing the organization for internal and external audits.
Escalate case-level issues and data discrepancies as required.
Collaboration & Documentation:
Interface with local office staff, vendors, and business partners to ensure smooth case processing.
Maintain accurate documentation in line with the PV System Master File and regulatory requirements.
Support safety agreement reconciliation activities with business partners.
Skills & Competencies:
Strong understanding of global pharmacovigilance regulations (FDA, EMA) and clinical development processes.
Hands-on experience in ICSR processing with demonstrated productivity and accuracy.
Attention to detail with strong organizational and analytical skills.
Proficiency in safety databases and Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).
Effective communication skills for cross-functional and vendor interactions.
Education & Experience Requirements:
Bachelor’s degree with 2+ years of relevant pharmacovigilance experience, OR
Associate’s degree with 6+ years of relevant experience, OR
High school diploma / GED with 8+ years of relevant pharmacovigilance experience.
Why Join This Role:
This is an opportunity to advance your career in pharmacovigilance operations within a globally recognized biopharmaceutical company. You will gain exposure to regulatory inspections, vendor oversight, and global safety reporting while contributing directly to patient safety and compliance excellence.
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