
Senior Clinical Data Specialist
22 hours ago
Job Title: Senior Clinical Data Specialist
About the RoleThis is an exciting opportunity for a detail-oriented and analytical individual to join our team as a Senior Clinical Data Specialist. In this role, you will be responsible for assessing and handling clinical data and case reports, particularly Suspected Unexpected Serious Adverse Reactions (SUSAR).
You will ensure compliance with global and local procedural documents while maintaining up-to-date knowledge of marketed drugs under litigation.
Main Responsibilities- Clinical Data Review:
- Author and edit clinical and periodic report comments in the Patient Safety database.
- Review medical sense of cases, including seriousness, coding, and associated clinical information.
- Provide detailed follow-up information and case updates as required.
- Query Management:
- Respond to queries from the Case Owner and detail requests for case changes.
- Offer product-specific advice, particularly for SUSAR cases.
- Documentation and Compliance:
- Document reviews and case comments in the Medical Review workflow.
- Ensure adherence to global and local procedural documents and policies.
- Education:
- Bachelor of Statistics, Bachelor of Technology, MBBS, MD, or MS.
- Skills:
- Extensive medical knowledge with the ability to critically assess clinical data.
- Attention to detail, analytical thinking, and strong communication skills.
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