Senior Associate – Pharmacovigilance Operations
Location: Hyderabad, India
Work Mode: On-site
Employment Type: Full-Time
Category: Medical Services
Job ID: R-233379
Posted Date: 12 January 2026
Role Overview
The Senior Associate – Pharmacovigilance Operations plays a critical role in global drug safety operations, acting as a key interface with US and EU health authorities. This position supports end-to-end safety case processing, regulatory reporting, vendor oversight, and inspection readiness, ensuring full compliance with FDA, EMA, and global pharmacovigilance regulations.
This role is ideal for experienced pharmacovigilance professionals with strong expertise in ICSR processing, clinical trial safety reconciliation, and regulatory submissions.
Key Responsibilities
Global Safety Reporting & Regulatory Compliance
Act as a local safety office representative and point of contact for FDA, EMA, and business partners
Support the submission of Individual Case Safety Reports (ICSRs) to FDA, EMA, and partner organizations
Ensure all expedited and non-expedited safety reports are submitted in compliance with regulatory timelines and contractual obligations
Evaluate ICSRs for reportability in accordance with global legislation and safety agreements
Case Processing & Clinical Safety Support
Perform medical and regulatory case reviews, including escalation of case-level issues
Support reconciliation of reportable events for sponsor-led clinical trials
Manage intake, triage, follow-up, and data entry queries related to ICSRs
Conduct US case follow-up activities and support ICSR literature review processes
Initiate unblinding activities as required
Vendor Oversight & Quality Management
Oversee vendor-managed case intake and processing activities to ensure quality and compliance
Monitor case quality metrics, identify trends, and drive continuous improvement
Ensure vendor adherence to approved processes, training requirements, and SOPs
Escalate data entry and quality issues in a timely manner
Audit, Inspection & QPPV Support
Support audit readiness and participate in health authority inspections and internal audits
Perform delegated activities under the QPPV framework as documented in the Pharmacovigilance System Master File (PSMF)
Provide E2B support including nullification and redistribution activities
Support business partner reconciliation activities as defined in safety agreements
Training & Cross-Functional Collaboration
Support development and delivery of pharmacovigilance training materials
Collaborate with local safety offices, vendors, and business partners to resolve operational issues
Perform additional pharmacovigilance-related duties as defined by SOPs or assigned by management
Education & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline
Experience Required:
Minimum 5 years of hands-on experience in Pharmacovigilance Operations
Proven experience in ICSR processing, regulatory submissions, and clinical trial safety reconciliation
Experience supporting FDA and EMA reporting is highly desirable
Key Skills & Competencies
Strong understanding of global pharmacovigilance regulations and reporting requirements
Solid knowledge of the clinical development process
High attention to detail with a focus on data quality and compliance
Proven ability to manage case processing with high productivity and accuracy
Proficiency in safety databases and pharmacovigilance systems
Strong working knowledge of Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Project)
Ability to collaborate effectively across global, cross-functional teams
Why Join This Role
This position offers the opportunity to work in a highly regulated, global pharmacovigilance environment with direct exposure to US and EU regulatory reporting. You will play a key role in ensuring patient safety, regulatory compliance, and operational excellence within a complex clinical and post-marketing safety landscape.
Apply now on thepharmadaily.com
Advance your career in global pharmacovigilance operations and regulatory compliance.
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