Senior Associate – Pharmacovigilance Operations
Location: Hyderabad, India | On-Site
Employment Type: Full-Time
Experience Level: 5+ Years
About the Role
We are seeking a Senior Associate in Pharmacovigilance Operations to support US/EU local safety office functions and act as a primary point of contact for FDA/EMA reporting. This role is critical in ensuring accurate, timely, and compliant processing of Individual Case Safety Reports (ICSRs) for clinical trials and post-marketing products.
The ideal candidate will have hands-on experience in ICSR intake, case review, vendor oversight, and regulatory reporting, with strong knowledge of global pharmacovigilance requirements.
Key Responsibilities
Act as the FDA/EMA contact for expedited safety reporting.
Perform reportable event reconciliation for Amgen-sponsored clinical trials.
Support vendor oversight for all case intake, processing, and quality monitoring.
Review ICSRs for completeness, accuracy, and compliance with regulatory and contractual requirements.
Make reporting decisions for expedited safety reports to FDA, EMA, and business partners.
Conduct case-level follow-up activities, including US case follow-up.
Manage queries related to intake, triage, and ICSR data entry.
Support literature review processes and other case processing functions.
Escalate data issues, initiate unblinding requests, and support BP reconciliation as needed.
Support training delivery related to conventions, SOPs, and pharmacovigilance processes.
Prepare for internal audits and Health Authority inspections, ensuring inspection readiness.
Provide support for LAO E2B functions including nullification and redistribution.
Required Knowledge & Skills
In-depth understanding of global PV regulations (FDA, EMA, GVP).
Familiarity with clinical development processes.
Hands-on experience in ICSR case processing with strong attention to detail.
Ability to manage vendor teams and ensure compliance with approved processes.
Proficient in safety databases and Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Project).
Strong communication, collaboration, and organizational skills.
Education & Experience
Bachelor’s degree in Life Sciences/Pharmacy/Related Field.
5+ years of experience in pharmacovigilance operations, ICSR processing, or related areas.
Why Join
Opportunity to work in a global, regulatory-focused PV environment.
Exposure to US/EU regulatory reporting requirements and vendor management.
Work with cross-functional teams supporting clinical trials and post-marketing safety.
Build a career in pharmacovigilance with growth opportunities.
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