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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

    Pay Grade:

    7-I

    Experience:

    0 - 3 Years

    Department:

    Clinical Development – Medical & Regulatory Affairs

    About Syngene:

    Incorporated in 1993, Syngene International Ltd. is a global discovery, development, and manufacturing organization focused on innovation. We provide integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Our esteemed clientele includes leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Our culture of innovation is driven by our passionate team of over 4,240 scientists dedicated to solving complex scientific challenges, improving R&D productivity, accelerating time to market, and reducing the cost of innovation.

    Job Description:

    As an Associate Research Physician, you will engage in clinical trial projects across various therapeutic areas, ensuring the accuracy and medical interpretation of clinical and safety data in compliance with regulatory and SOP requirements.

    Key Responsibilities:

    • Conduct medical reviews, assessments, and interpretations of clinical and safety data.
    • Support the preparation and review of protocol-related documents such as Investigator’s Brochure, Informed Consent Document, and Clinical Study Report (CSR).
    • Review MedDRA and WHO Drug Insight coding as required.
    • Assist the Senior Research Physician in generating Serious Adverse Event (SAE) narratives and conducting quality reviews of similar events.
    • Communicate SAEs to all stakeholders in accordance with guidelines and internal SOPs, tracking compliance as needed.
    • Draft the Integrated Summary of Safety and Efficacy for designated clinical trial projects.
    • Collaborate with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitors on protocol and protocol synopsis reviews for BA/BE and phase studies.
    • Prepare Medical Monitoring Plans (MMP) and Risk Evaluation and Mitigation Strategies (REMS), if applicable.
    • Complete Site Feasibility Questionnaires (SFQs) and summaries for patient-based studies.
    • Train study team members and address protocol-related queries promptly.
    • Provide input on deliverables with accurate timelines and processes, ensuring quality in regulatory documents.
    • Manage documents through multiple review cycles and deadlines.

    Educational Qualification:

    • MBBS/MD in Pharmacology.

    Experience:

    • Up to 2 years in a relevant field.

    Behavioral Skills:

    • Strong communication skills and a collaborative team player.
    • Ability to thrive in a dynamic, ambiguous environment.
    • Proficient in meeting tight deadlines and prioritizing workloads.
    • Creative thinker with a focus on developing innovative solutions.
    • Detail-oriented and focused employee.

    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 and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by applicable legislation. We also provide reasonable accommodations for qualified individuals with disabilities.

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