Safety Science Specialist – Clinical Safety Operations (Bangalore, India)
Location: Bangalore, India
Category: Clinical
Job Type: Full-Time
Job ID: 255848
Work Model: Onsite
Position Overview
This is an excellent opportunity for a skilled Safety Science Specialist to join a global clinical research organization focused on high-quality pharmacovigilance and safety operations. The role is responsible for managing the complete adverse event (AE) and serious adverse event (SAE) lifecycle for clinical trials and post-marketing settings. The position requires strong expertise in case processing, narrative writing, regulatory reporting, and adherence to global PV standards.
The Safety Science Specialist will support multiple client projects, ensuring compliance with regulatory requirements and delivering safety services efficiently and with accuracy.
Key Responsibilities
Manage the intake and processing of all adverse event reports (spontaneous, solicited, and clinical trial).
Enter safety data into validated AE databases and tracking systems with precision.
Review AE/SAE reports for completeness, accuracy, and expedited reporting eligibility.
Prepare high-quality patient narratives and code events using MedDRA.
Assess listedness against approved product labels for marketed products.
Identify missing clinical information and initiate follow-up with investigators or relevant stakeholders.
Ensure appropriate medical review is completed for all cases.
Submit expedited reports to clients, regulatory authorities, ethics committees, investigators, and third-party vendors within required timelines.
Report safety endpoints according to study requirements.
Assist in database reconciliation in coordination with Data Management teams.
Manage Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including submission tracking.
Maintain and update AE tracking systems and project documentation.
Conduct quality review or peer review of processed reports, identifying trends and recommending actions.
Maintain up-to-date knowledge of SOPs, Work Instructions, and global PV regulations.
Support preparation of safety metrics, client meetings, and Safety Committee/DSMB documentation.
Assist with audit and inspection readiness activities.
Participate in root cause analysis and CAPA development for quality issues.
Ensure proper archiving of safety files at the end of projects.
Collaborate effectively with internal and external stakeholders to maintain strong PSS relationships.
Experience Required
3 to 5 years of hands-on Pharmacovigilance experience is mandatory.
Clinical Trial safety case processing experience is essential.
Experience in AE/SAE case processing, narrative writing, query management, safety databases, and regulatory submissions is required.
Candidates with PharmD plus 1-year residency or fellowship may be considered as meeting experience criteria.
Experience in related areas such as Medical Affairs, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance is an added advantage.
Prior experience in the pharmaceutical, biotechnology, or CRO industry is strongly preferred.
Education Requirements
Degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, Medical Sciences, or a related discipline.
Equivalent experience may be considered in place of formal educational requirements.
Skills and Competencies
High level of accuracy and attention to detail.
Strong written and verbal communication skills.
Ability to work independently with minimal supervision.
Proficiency in MS Office and Windows applications is beneficial.
Strong organizational and presentation skills.
Ability to mentor and train junior team members.
Effective team collaboration and stakeholder management.
Job Location
Bangalore, India
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