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    Medical Monitor

    Syngene
    0-3 years
    Not Disclosed
    Bangalore
    10 Oct. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Associate Research Physician/Associate Manager

    Job Location:

    Bangalore

    Experience:

    0 - 3 Years

    Department:

    Clinical Development – Medical & Regulatory Affairs

    About Syngene:

    Incorporated in 1993, Syngene International Ltd. is an innovation-focused global organization providing integrated scientific services across the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Our clientele includes leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Driven by a passionate team of 4,240 scientists, we aim to solve scientific challenges, improve R&D productivity, accelerate time to market, and lower innovation costs.

    Job Description:

    Role: Associate Research Physician/Associate Manager

    Key Responsibilities:

    • Participate in clinical trial projects across various therapeutic areas, conducting medical reviews and interpreting clinical and safety data to ensure accuracy and compliance with regulatory and SOP requirements.
    • Assist in the preparation and review of protocol-related documents, including the Investigator’s Brochure, Informed Consent Document, and Investigator’s Undertaking.
    • Review MedDRA and WHO Drug Insight coding as needed for projects.
    • Support the Senior Research Physician in generating Serious Adverse Event (SAE) narratives and conducting quality reviews.
    • Communicate SAEs to stakeholders in accordance with guidelines and track communications for clinical trials.
    • Lead the drafting of the Integrated Summary of Safety and Efficacy for clinical trial projects as assigned.
    • Collaborate with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitors to review protocols and protocol synopses for BA/BE and phase studies.
    • Prepare the Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS), as applicable.
    • Create Site Feasibility Questionnaires (SFQs) and summaries for patient-based studies.
    • Train study team members and address protocol-related queries in a timely manner.
    • Provide input on deliverables, timelines, and processes to support the completion of quality regulatory documents.
    • Manage documents through multiple review cycles and deadlines.

    Educational Qualification:

    MBBS, MD in Pharmacology

    Experience:

    Up to 2 Years

    Behavioral Skills:

    • Strong communication skills and ability to work effectively in a team.
    • Adaptable to dynamic and ambiguous environments.
    • Capable of meeting tight deadlines and prioritizing workloads.
    • Creative thinker with the ability to develop innovative solutions.
    • Detail-oriented and focused on responsibilities.

    Equal Opportunity Employer:

    Syngene is committed to providing equal employment opportunities (EEO) to all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity, genetic information, marital status, or any other characteristic protected by applicable law. Reasonable accommodations will be provided for qualified individuals with disabilities.

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