Specialist I – Clinical Safety / Pharmacovigilance
Location: Bangalore, India
Job Type: Full-Time
Department: Clinical Safety / Pharmacovigilance
Experience Required: 1–5 Years (depending on qualification)
Job Overview
We are seeking a detail-oriented and motivated Specialist I to support Clinical Safety and Pharmacovigilance operations. This role focuses on end-to-end adverse event (AE) processing, including case intake, evaluation, reporting, and compliance with global regulatory requirements. The ideal candidate will contribute to safety data management across clinical trials and post-marketing environments, ensuring high-quality deliverables within defined timelines.
Key Responsibilities
Manage and process adverse event (AE) and serious adverse event (SAE) reports from clinical trials and post-marketing sources
Perform accurate data entry, case assessment, and validation in safety databases
Review case information for completeness, consistency, and regulatory compliance
Prepare detailed patient narratives and perform MedDRA coding
Assess case listedness and support expedited reporting requirements
Identify missing or critical safety information and initiate follow-ups
Ensure timely submission of safety reports to regulatory authorities, clients, ethics committees, and other stakeholders
Maintain and update adverse event tracking systems and project documentation
Support preparation and submission of expedited safety reports (ESRs), periodic safety reports (PSRs), PSURs, DSURs, and IND reports
Conduct database reconciliation with data management teams or sponsors
Participate in signal detection, trend analysis, and safety surveillance activities
Perform peer review and quality checks of safety cases and reports
Assist in preparation of safety listings, metrics, and project reports
Contribute to audit readiness, inspections, and CAPA (Corrective and Preventive Actions) activities
Support development and updates of Safety Management Plans and reconciliation plans
Collaborate with cross-functional teams and participate in project meetings
Qualifications
Bachelor’s, Master’s, PharmD, or equivalent degree in Life Sciences, Pharmacy, Nursing, or related field
Relevant safety or pharmacovigilance experience ranging from 1 to 5 years based on educational background
Strong understanding of pharmacovigilance processes, AE/SAE reporting, and safety databases
Knowledge of ICH-GCP guidelines and global regulatory requirements
Familiarity with MedDRA coding and clinical safety documentation
Proficiency in Microsoft Office and safety database systems
Skills and Competencies
High attention to detail with strong analytical and problem-solving skills
Effective written and verbal communication skills
Ability to manage multiple priorities in a fast-paced environment
Strong teamwork and collaboration abilities
Capability to work independently with minimal supervision
Good understanding of medical and drug terminology
Work Environment
Office-based role with occasional travel requirements (up to 5%) depending on project needs
Why Join This Role
This opportunity offers exposure to global pharmacovigilance operations, enabling professionals to build expertise in clinical safety, regulatory compliance, and end-to-end case processing while contributing to patient safety and drug lifecycle management.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Siliguri |Illinois :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Austria |Vienna :
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