Specialist I – Clinical Safety / Pharmacovigilance
Location: Bangalore, Karnataka, India
Category: Clinical / Drug Safety / Pharmacovigilance
Job ID: 26731
Industry: Pharmaceutical / Biotechnology / CRO
Experience Required: 1–5 years of Safety or relevant Clinical/Pharma industry experience (based on educational qualification)
Job Overview
We are seeking a detail-oriented Specialist I – Clinical Safety to support end-to-end pharmacovigilance and clinical safety operations. This role involves managing adverse event (AE) and serious adverse event (SAE) processing from clinical trials and post-marketing sources, ensuring timely regulatory reporting, and maintaining compliance with global safety standards.
The position requires strong knowledge of Good Clinical Practice (GCP), ICH guidelines, global adverse event reporting requirements, and safety database management. This opportunity is ideal for professionals looking to advance their careers in drug safety, regulatory compliance, and pharmacovigilance operations within a global clinical environment.
Key Responsibilities
Adverse Event Case Processing
Manage receipt, review, and processing of adverse event (AE) and serious adverse event (SAE) reports from clinical trials and spontaneous sources.
Perform accurate data entry into safety databases and tracking systems.
Review cases for completeness, accuracy, and eligibility for expedited reporting.
Write patient narratives and code adverse events using MedDRA terminology.
Assess listedness for marketed products against approved labeling.
Identify missing clinically significant information and ensure appropriate follow-up.
Regulatory Reporting & Compliance
Process and submit expedited safety reports (ESRs) and periodic safety reports (PSRs) within regulatory timelines.
Ensure timely submission of SAE reports to clients, regulatory authorities, ethics committees, investigators, and partners.
Assist in preparation of PSURs, DSURs, Annual IND reports, and other aggregate safety reports.
Maintain compliance with worldwide regulatory requirements for investigational and marketed products.
Safety Systems & Documentation
Maintain adverse event tracking systems and project safety files.
Perform database reconciliations with Data Management teams and sponsors.
Support safety database conventions and ensure quality review of processed cases.
Contribute to safety metrics reporting and monthly project status updates.
Quality & Continuous Improvement
Participate in signal detection, trend analysis, and pattern recognition activities.
Support root cause analysis and CAPA plan development.
Assist in audit and inspection readiness activities.
Review and update Safety Management Plans (SMPs) and reconciliation plans.
Collaboration & Mentorship
Support cross-functional project teams and client meetings.
Mentor and train junior safety staff on case processing and regulatory compliance.
Coordinate archiving of safety study files at project completion.
Educational Qualifications
Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field.
Minimum education and experience combinations include:
Non-degree with 2+ years of Safety experience or 4–5 years of relevant industry experience
Associate degree with 2+ years of Safety experience or 3–4 years of relevant experience
Bachelor’s degree (BS/BA) with 1–2 years of Safety experience or 2–3 years of relevant experience
Master’s degree (MS/MA) with 1–2 years of Safety experience or 2 years of relevant experience
PharmD with 1–2 years of Safety experience or 2 years of relevant experience (Residency/Fellowship may be considered equivalent experience)
Safety experience includes hands-on AE/SAE processing, narrative writing, query management, safety database usage, and regulatory submissions.
Relevant experience includes roles in Medical Affairs, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance within pharmaceutical, biotechnology, or CRO environments.
Required Skills & Competencies
Strong understanding of GCP and ICH Guidelines.
Knowledge of global adverse event reporting requirements.
Familiarity with pharmacovigilance processes for investigational and marketed products.
High level of accuracy and attention to detail.
Strong written and verbal communication skills.
Proficiency in MS Office and safety database systems.
Ability to work independently and manage timelines effectively.
Strong teamwork and stakeholder collaboration skills.
Work Environment
Office-based role.
Up to 5% travel may be required, including occasional overnight stays depending on project needs.
This role offers an excellent opportunity to build expertise in pharmacovigilance, regulatory compliance, and clinical safety operations within a global clinical research environment.
Apply now through ThePharmaDaily.com to advance your career in Clinical Safety, Drug Safety Operations, and Global Pharmacovigilance.
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