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    Clinical Research Officer

    Ciel
    3-4 years
    2-5 Lacs P.A.
    Nagpur
    10 March 4, 2024
    Job Description
    Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

    Share resume at: amol.ingle@cielhr.com

    Job description

    Role:- Clinical Research Officer

    Location: Nagpur (work from office)

    3-4 years of experience

    Share resume at: amol.ingle@cielhr.com

     

    Role & responsibilities


     

    Job Responsibility: Bioavailability & Bioequivalence (Clinical) Studies

     

    • Planning, designing and execution of bioavailability and bioequivalence studies undertaken for international and domestic markets.

     

    • Planning and execution of BE studies in India.

     

    • CRO identification, selection and budget negotiation.

     

    • Review of In vitro Dissolution data (CDP data) for proceeding for the Bioequivalence

     

    study.

     

    • Shipment of Investigational Medicinal Product (IMP) to CRO Site for performing the

     

    Bioequivalence/clinical studies.

     

    • Review of BE study protocols and Bioanalytical study report, Pharmacokinetic and statistical study report and Clinical study report to ensure its completeness with respect to

     

    scientific and relevant regulatory agency requirements.

     

    • Review of Method validation, Bioanalytical study documents and statistical report.

     

    • To provide timely response to the queries raised by regulatory authorities after submission of registration dossier and pre-submission queries raised by customer.

     

    • Interpretation of available data to recommend suitable study design and approach for the bio studies.

     

    • To perform thorough literature search in order to finalize the bio strategy.

     

    • To investigate the plausible causes of bio-equivalence failure in order to understand the reason of failure and to provide the opinion on dissolution behavior/study design that

     

    could help us to achieve the success in upcoming bioequivalence study.

     

    • Closely worked with formulation development, regulatory affairs and international marketing team.

     

    • Preparation and review of Module 2.7.1

     

    • Preparation of clinical and nonclinical overview

     

    • eCTD Submission of Module 5.

     

    • Review of CDISC datasets for USFDA studies.



     

    Job Responsibility: Pharmacovigilance

     

    • Overall responsibility of Pharmacovigilance functions.

     

    • Collection, evaluation and submission of Individual Case Safety Reports,

     

    • Database entry ensuring accuracy and consistency in line with PPPs case processing SOPs.

     

    • Preparation & Submission of PSUR reports to regulatory Authorities.

     

    • Preparation of Signal Detection Reports and Risk Management Plans.

     

    • Implementation and maintenance of Safety Data Exchange Agreements and transmission and reconciliation of Pharmacovigilance data, ensuring compliance with the relevant

     

    legislation.

     

    • Literature searching.

     

    • Narrative writing.

     

    Role: Clinical research Scientist

    Industry Type: Pharmaceutical & Life Sciences

    Department: Research & Development

    Employment Type: Full Time, Permanent

    Role Category: Pharmaceutical & Biotechnology

    Education

    PG: M.Pharma in Any Specialization, Medical-MS/MD in Any Specialization

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