HR Manager at Biosite Research Pvt Ltd
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Biosite - Medical Monitor - MBBS/MD/Pharmacology (1-5 yrs)
- Perform core medical monitoring activities for multiple assigned studies, including input into study design, protocol and regulatory approval strategy,
- Prepare and execute successful SEC Presentation in CDSCO meetings.
- Response to inquiries from the sites, regulatory authorities, IRBs/IECs
- Responsibility for the management of all medical issues which arise in the course of the clinical study (Phase II - IV/PMS), presentation to investigator meetings, safety review committees.
- Write the study Medical Monitoring Plan (MMP) in co-ordination with the Safety Monitoring Plan (SMP)
- Perform the medical review of patient data and patient profiles during the study period and provide input for the clinical study report (CSR).
- Provide medical oversight of assigned studies, including medical monitoring, evaluation of patients- eligibility, interpretation and appropriate management and reporting of patient safety data throughout the lifecycle of the study in accordance with ICH Good Clinical Practice, applicable regulatory guidelines and company standard operating procedures.
- Review adverse events (AEs), serious adverse events (SAEs) and AEs of Special Interest, and participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action.
- Provide medical expertise, guidance, and therapeutic area training of project team as required.
- Act as medical advisor to project manager when required.
- Guide Statistics Analysis Team during Data Analysis for CSR.