Specialist I – Clinical Safety / Pharmacovigilance
Location: Bangalore
Job Type: Full-Time
Application Deadline: April 30, 2026
Job Requisition ID: 26731
Job Overview
We are hiring a detail-oriented Specialist I – Clinical Safety / Pharmacovigilance to support clinical safety and pharmacovigilance operations related to adverse event processing, expedited safety reporting, and safety data management. This role is responsible for handling adverse event reports from clinical trials and post-marketing sources while ensuring timely and compliant reporting to clients, regulatory authorities, ethics committees, and investigators.
The ideal candidate will contribute to pharmacovigilance case processing, regulatory submissions, safety database management, reconciliation, and aggregate safety reporting in accordance with global compliance standards and pharmacovigilance regulations.
Experience Required
1–2 years of pharmacovigilance/safety experience for candidates with Bachelor’s, Master’s, or PharmD degree
2+ years of safety experience for candidates with Associate Degree or non-degree qualifications
Experience processing AE/SAE reports, narrative writing, safety queries, and regulatory submissions
Experience working within safety databases and adverse event tracking systems
Relevant pharmaceutical, biotechnology, or CRO industry experience may be considered
Knowledge of adverse event reporting for marketed and investigational products
Key Responsibilities
Manage receipt and processing of adverse event reports from spontaneous sources and clinical trials
Enter safety data into adverse event databases and tracking systems
Review adverse events for completeness, accuracy, and expedited reporting requirements
Write patient narratives and code adverse events using MedDRA
Assess listedness against product labeling where applicable
Identify missing clinically significant information and conduct follow-up activities
Ensure timely processing and submission of expedited reports to regulatory authorities and stakeholders
Submit Serious Adverse Event (SAE) reports within study-defined timelines
Perform database reconciliation with Data Management teams and sponsors/clients
Process and review Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
Maintain adverse event tracking systems and project safety files
Assist with PSURs, DSURs, Annual IND Reports, and other aggregate safety reports
Conduct peer/quality review of processed safety reports
Support signal detection and trend/pattern recognition activities
Generate monthly status and project-specific safety reports
Mentor junior safety staff on case handling and adverse event reporting
Maintain compliance with SOPs, Work Instructions, and pharmacovigilance guidelines
Assist in updating Safety Management Plans and reconciliation plans
Participate in project team and client meetings
Prepare safety files for archiving at project completion
Contribute to CAPA development, root cause analysis, audits, and inspection readiness
Support review of cumulative safety data for DSMBs and regulatory submissions
Required Qualifications
Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field
Educational/Experience combinations accepted include:
Non-degree + 2 years safety experience / 4–5 years relevant experience
Associate Degree + 2 years safety experience / 3–4 years relevant experience
BS/BA + 1–2 years safety experience / 2–3 years relevant experience
MS/MA + 1–2 years safety experience / 2 years relevant experience
PharmD + 1–2 years safety experience / 2 years relevant experience
PharmD residency/fellowship may count as relevant experience
Required Skills
Strong attention to detail and high level of accuracy
Good written and verbal communication skills
Strong teamwork and collaboration abilities
Knowledge of medical and drug terminology
Familiarity with Good Clinical Practice (GCP) and ICH Guidelines
Understanding of global regulatory requirements for adverse event reporting
Ability to work independently with minimal supervision
Proficiency in Microsoft Office and Windows applications
Work Environment
Office-based environment
Up to 5% travel required, including occasional overnight stays based on project needs
Why Join This Opportunity
This is an excellent opportunity for professionals looking to advance their career in pharmacovigilance, drug safety, adverse event reporting, clinical safety operations, and regulatory compliance within a globally recognized clinical research environment.
Apply now to build your future in clinical safety and pharmacovigilance operations.
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