Job Title: Safety Science Coordinator II
Location: Bangalore
Category: Clinical
Job ID: 254692
Job Overview
The Safety Science Coordinator II assists in Clinical Safety and PSS operations, managing adverse event reporting from clinical trials and/or post-marketing data. This role ensures high-quality, timely submission of safety information to clients and regulatory agencies, while maintaining compliance with relevant legal and regulatory requirements.
Key Responsibilities
Adverse Event Processing
Process adverse event reports from any source according to client/sponsor plans.
Manage receipt and processing of all adverse event reports (spontaneous or clinical trial).
Perform data entry of safety data into adverse event databases and tracking systems.
Review adverse events for completeness, accuracy, and regulatory compliance.
Write patient narratives and code adverse events accurately using MedDRA, if applicable.
Identify missing clinically significant information and generate queries, consulting medical staff if needed.
Ensure appropriate medical review for all cases.
Regulatory Reporting
Prioritize and submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and third-party vendors within required timelines.
Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), maintain tracking systems, and assist with database reconciliation.
Maintain study/project documentation as per agreed requirements.
Ensure compliance with governing regulatory requirements and study/project plans.
Quality & Oversight
Support peer review and quality review of processed reports.
Maintain comprehensive knowledge of SOPs, work instructions, guidance documents, and regulatory directives related to safety management and pharmacovigilance.
Assist in quality issues management and audit/inspection preparation.
Support preparation for client meetings and liaise with client contacts as needed.
Team Support & Training
Support and mentor PSS staff as needed.
Contribute to generation and maintenance of PSS metrics and monthly status reports.
Offer peer support and foster a collaborative team environment.
Qualifications & Requirements
Education:
Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area (preferred).
Experience:
2–3 years of drug safety experience.
Exposure to clinical trial case processing.
Skills & Competencies:
High degree of accuracy and attention to detail.
Team player with mentoring ability.
Strong written and verbal communication skills.
Ability to work independently with moderate supervision.
Proficiency with MS Office and Windows applications.
Work Environment
Office/Hybrid work environment.
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Netherlands |Remote Australia :
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