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    Medical Monitor–Clinical Trials & Pharmacovigilance

    Jeevan Scientific Technology Limited
    Freshers years
    ₹15,000 - ₹35,000 a month
    Hyderabad
    10 Jan. 19, 2024
    Job Description
    Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill
    • Provide inputs on protocol preparation from clinical perspective, based on therapeutic area & study phase
    • Prepare and Participate in Subject Expert Committee (SEC) Meetings & similar meetings with regulatory agency such as CDSCO
    • Responsible for Sponsor facing clinician role, for all clinical decisions, during pre-study, study execution, post study activities till clinical study report
    • Provide protocol and therapeutic area training to study teams (both internal and external).
    • Provide response to study investigator/Ethics committee queries.
    • Prepare study specific medical monitoring plan
    • Review of Protocol deviations, on real time basis
    • Review of Clinical study report / Site Monitoring Plan etc
    • Review study subject reports (like Medical history, lab reports, ECG report, cytology, 2D- ECHO, CT, Bone Scan reports, any clinical assessments etc, as applicable) for eligibility in coordination with Project Manager/Designee
    • SAE management if any, follow up with sites/ investigator for SAE updates and updating sponsor accordingly.
    • Develop & Review protocol amendments (if required) and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan
    • Responsible for review of Adverse event and Serious adverse event data in the clinical trial for its completeness and accuracy
    • Responsible for review of Serious adverse event (SAE) forms received from trial sites
    • To communicate various safety related aspects with the stake holders i.e., Study team to site, and various regulatory agencies and Sponsor team
    • Responsible for preparation of Serious adverse event (SAE) reporting Data Elements for Reporting Serious Adverse Events Occurring in A Clinical Trial
    • Responsible for coordination with internal Regulatory and operation team for completion of SAE forms, reconciliation and tracker compilation.
    • Responsible for ensuring electronic reporting of SAEs to DCGI, Chairman of Ethics Committees and Head of Institutions within stipulated timelines
    • Responsible for Preparation of individual case narratives
    • Responsible for preparation of the CSR
    • AE, Concomitant Medication, Medical History, Vital signs, Physical examination, listing review
    • Performing the Case Analysis and Peer Review (Quality check)
    • Perform medical review (including verifying the coding & labeling reviewing narratives causality statement medical aspect of follow-up request)
    • Validate follow-up request and perform medical assessment of the case for the Category I and II cases
    • Prioritize workloads to ensure expedited cases are processed within defined timelines
    • Responsible for the timely completion of individual cases and meeting the SLA for data entry and case analysis activity as per SOP
    • Approval and the locking of Category I cases
    • Responsible for the timely reception of an individual case on a daily basis
    • Responsible for registration in e-log book and for the duplicate search process
    • Ensure quality and timely creation and closure of PV query as per SOP
    • Ensure the filing of PV dossier and documents as per the SOP

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