Senior Associate – Pharmacovigilance Operations
Location: Hyderabad, India
Work Mode: On-site
Category: Medical Services / Pharmacovigilance
Job ID: R-233379
Date Posted: January 12, 2026
Job Overview
The Senior Associate – Pharmacovigilance Operations will play a critical role in supporting global safety operations by acting as a key liaison with US and EU regulatory authorities, including the FDA and EMA. This position is responsible for end-to-end individual case safety report (ICSR) management, vendor oversight, regulatory submissions, and ensuring compliance with global pharmacovigilance regulations and contractual obligations.
Key Responsibilities
Safety Operations & Regulatory Compliance
Act as a local safety office contact for US/EU regions and as a primary interface with FDA, EMA, and business partners.
Ensure accurate and timely submission of ICSRs to regulatory authorities and business partners in compliance with global regulations and safety agreements.
Support reporting decisions for expedited safety reports and ensure submissions are completed within defined regulatory timelines.
Maintain inspection readiness and support activities delegated by the QPPV in accordance with the Pharmacovigilance System Master File (PSMF).
Case Management & Vendor Oversight
Perform detailed case review, including intake, triage, data entry, and follow-up activities.
Oversee vendor-managed case processing activities, ensuring high-quality deliverables and compliance with approved processes and training requirements.
Analyze case quality metrics, identify trends, and escalate case-level or data entry issues as required.
Manage reportable event reconciliation for sponsored clinical trials and business partner agreements.
Audits, Inspections & Training
Support internal audits and external health authority inspections within the scope of the role.
Assist in the development and delivery of pharmacovigilance and convention-related training materials.
Serve as a representative during health authority inspections and internal process audits.
Additional Responsibilities
Support business partner reconciliation activities as per safety agreements.
Provide E2B support, including nullification and redistribution activities.
Support literature review and other safety case processing functions as required.
Perform additional duties in line with Standard Operating Procedures (SOPs) or as assigned by management.
Key Activities
Review and reconcile non-matching safety data between clinical and safety databases.
Manage and coordinate vendor clinical safety reconciliation teams.
Conduct US case follow-up activities and initiate unblinding when required.
Review and respond to adverse event intake, triage, and submission queries.
Ensure compliance with global reporting criteria, timelines, and contractual obligations.
Collaborate with local affiliates, vendors, and business partners to support seamless case processing.
Required Knowledge & Skills
Strong understanding of global pharmacovigilance regulations and reporting requirements.
Hands-on experience with ICSR processing and case quality management.
Familiarity with the clinical development lifecycle.
High attention to detail with proven ability to manage complex safety data.
Proficiency in pharmacovigilance safety databases and tools.
Strong working knowledge of Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Project).
Education & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
Minimum of 5 years of direct experience in pharmacovigilance operations, safety case processing, or regulatory safety reporting.
Why This Role Matters
This role is integral to ensuring patient safety, regulatory compliance, and the integrity of global safety operations. The Senior Associate will contribute directly to high-impact pharmacovigilance activities across clinical trials and post-marketing safety surveillance.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
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Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Surabaya |Japan :
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Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba | Yavne |Remote :
Bishop | Blue Bell | Remote - South America (Latin Americal) | Melbourne | Nairobi | Remote - Middle East | Regulatory Labeling Manager (NA and LATAM Only) | Faridabad | Ireland | Tulsa | Zaragoza | Remote - Europe | Lenexa | McFarland | Hammond | Medan | Minnesota | Remote - Africa | Riga | Victoria | Castlebar | Lousiana | Springville | French | Bountiful | Hungary | Slovakia | Leinster | Remote, USA | Green Way | Remote | Thailand | Switzerland | Manipal | Xzagreb | Texas | Belgium |Republic of Colombia :
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South Africa | Midrand |Nišava District :
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