Senior Associate – Pharmacovigilance Operations
Location: Hyderabad, India
Work Mode: On-site
Employment Type: Full-Time
Job ID: R-233379
Category: Medical Services / Pharmacovigilance
Date Posted: 12 January 2026
Job Overview
We are seeking an experienced Senior Associate – Pharmacovigilance Operations to support global safety operations with a strong focus on US and EU regulatory reporting. This role will act as a local safety office and primary point of contact for FDA and EMA submissions, ensuring timely, accurate, and compliant processing of Individual Case Safety Reports (ICSRs).
The position plays a critical role in vendor oversight, case quality management, inspection readiness, and regulatory compliance across clinical and post-marketing safety activities.
Key Responsibilities
Global Safety Reporting & Regulatory Compliance
Act as US/EU local safety office and point of contact for FDA, EMA, and business partner safety reporting
Ensure timely submission of ICSRs to FDA, EMA, and business partners in accordance with regulatory timelines and contractual obligations
Support reporting decisions for expedited safety reports
Maintain inspection readiness in alignment with the PV System Master File (PSMF) and QPPV delegation
Case Management & Reconciliation
Perform and support reportable event reconciliation for sponsor-led clinical trials
Review non-matching safety data across clinical and safety databases
Conduct case review, follow-up activities, and escalation of case-level issues
Support AE intake, triage, data entry, and submission-related queries
Initiate unblinding activities as required
Vendor & Partner Oversight
Oversee vendors responsible for case intake, processing, and reconciliation
Monitor case quality metrics and identify trends to drive continuous improvement
Ensure vendor compliance with approved processes, SOPs, and training requirements
Support reconciliation activities with business partners as per safety agreements
Quality, Training & Inspection Support
Support audit readiness for Health Authority inspections and internal process audits
Participate in and support convention-related pharmacovigilance training delivery
Provide LAO E2B support, including nullification and redistribution
Support ICSR literature review activities and additional case processing tasks as required
Knowledge & Skills Required
Strong understanding of global pharmacovigilance regulations (FDA, EMA, ICH)
Sound knowledge of the clinical development process
Demonstrated experience in ICSR processing with high quality and productivity
Excellent attention to detail and issue escalation capability
Proficiency with pharmacovigilance safety databases
Strong working knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Project)
Education & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline
Minimum 5+ years of hands-on experience in pharmacovigilance operations, safety reporting, or case processing
Why This Role
High-visibility role supporting global FDA and EMA safety reporting
Opportunity to work at the intersection of clinical trials, post-marketing safety, and regulatory compliance
Exposure to vendor oversight, inspections, and QPPV-aligned responsibilities
Career growth within global pharmacovigilance and medical services operations
Apply now on thepharmadaily.com to advance your career in global pharmacovigilance operations and regulatory safety reporting.
Gujarat :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
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