**Immediate Joiner**

Work Location: Remote
Work Schedule: Monday to Friday (5 Days a Week)
Working Hours: 9:30 AM 6:00 PM

Clinical Safety Specialist:

- Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
- Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs
- Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
- Ensure consistency in the assessment of clinical safety events
- Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Responsible Adverse Device Effects (U[S]ADEs) and potential complaints
- Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP
- Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
- Assists (Lead) Clinical Safety Specialist with authoring Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
- Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
- Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms
- Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings
- Support study audit for Safety-specific topics
- Assist with helping to facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC)
- Support database snapshot activities (e.g., meet with study team, review timelines,



perform reconciliation and data cleaning activities to be audit & snapshot ready)
- Prepare, attend and/or lead Safety Trending meetings
- Perform other Clinical Safety tasks as assigned

If Interested share your CV on:

[email protected]

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📌 Clinical Safety Specialist (Gurugram)
🏢 PERSOL
📍 Gurugram