Job Title: Safety Science Coordinator II
Location: Bangalore, India
Category: Clinical
Job ID: 254692
The Safety Science Coordinator II supports Clinical Safety and Pharmacovigilance operations, managing adverse event (AE) processes from clinical trials and post-marketing sources. The role ensures timely and accurate processing, reporting, and submission of safety data to clients and regulatory authorities, maintaining high-quality service in compliance with regulatory standards.
Adverse Event Processing
Process adverse event reports from any source in accordance with client/sponsor plans.
Manage receipt and processing of all AE/SAE reports, including spontaneous and clinical trial data.
Data entry of safety data into AE databases and tracking systems.
Review AEs for completeness, accuracy, and appropriateness for expedited reporting.
Write patient narratives and code AEs using MedDRA (if applicable).
Conduct listedness assessment against product labels (for marketed products, if applicable).
Identify clinically significant missing information and generate queries in consultation with medical staff.
Ensure cases receive appropriate medical review.
Prioritize and submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, vendors, and internal personnel within agreed timelines.
Safety Reporting & Documentation
Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including submission and tracking.
Maintain project and central files for documentation.
Support quality or peer review of processed reports.
Assist in database reconciliation and associated activities.
Maintain study/project level documentation per agreed requirements.
Training & Mentorship
Support and mentor PSS staff as required.
Provide input for monthly status reports and PSS metrics.
Assist in the preparation of client meetings and liaise with client contacts as needed.
Quality & Compliance
Maintain understanding and adherence to SOPs, Work Instructions (WIs), guidance documents, and regulatory directives.
Support quality issue management, audits, and inspection preparation.
Ensure compliance with regulatory requirements and study/project plans.
Take responsibility for the quality of processed data.
Other Duties
Perform additional tasks assigned by management.
Responsibilities may vary depending on role assignment within the team.
Minimum Required
2–3 years of drug safety experience.
Experience in clinical trial case processing.
Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Skills & Competencies
High accuracy and attention to detail.
Team player with ability to provide peer support.
Strong written and verbal communication skills.
Ability to work independently with moderate supervision.
Good keyboard skills; familiarity with MS Office and Windows applications.
Mentoring skills preferred.
Office-based or hybrid work environment.
Pharmacovigilance
Clinical Safety
AE/SAE Processing
Safety Reporting
Regulatory Compliance
PSS Operations
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