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    Junior Micc Associate

    Navitas Life Sciences
    1-3 years
    Not Disclosed
    Bangalore
    10 Nov. 7, 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

    Junior MICC Associate

    Location: [Location]
    Job Type: Full-Time, Permanent

    Job Description

    We are seeking a Junior MICC Associate to join our growing team within the Medical Information Contact Centre (MICC) for the Pharmacovigilance function. In this role, you will be responsible for ensuring compliance with global and local regulations, maintaining data integrity, and providing efficient support for safety reporting processes. You will be the first point of contact for medical information inquiries, processing case reports, and ensuring accurate documentation and follow-up.

    Key Responsibilities

    Medical Information and Pharmacovigilance Support

    • Receive and manage inquiries through calls, emails, and other communication channels (AE, PQC, MI & GI), ensuring timely intake, case registration, and follow-up.
    • Handle inquiries in a detailed-oriented and professional manner, demonstrating a friendly and helpful attitude at all times.
    • Ensure appropriate escalation of issues to a supervisor when necessary.
    • Provide translation support for inquiries that are not in the primary language (e.g., English).
    • Maintain data confidentiality and adhere to company policies on protecting personal and client data.

    Case Safety Report Management

    • Data entry of Individual Case Safety Reports (ICSRs) into the safety database.
    • Review and evaluate adverse event (AE) case information to determine appropriate actions based on internal policies and procedures.
    • Process all cases to meet defined timelines, quality, and productivity targets, ensuring compliance with project SLAs and KPIs.
    • Code medical history, events, drugs, procedures, indications, and lab tests using appropriate dictionaries (e.g., MedDRA, Company Product Dictionary, WHO-DD).
    • Draft and/or review medically relevant safety narratives, ensuring chronological accuracy and completeness.
    • Verify the completeness and accuracy of data entered into various fields and correct any discrepancies.
    • Prepare, archive, and maintain source documents as required.

    Quality Review and Mentorship

    • Review feedback from Quality Reviewers (QR) and ensure feedback comments are addressed in the revised cases.
    • Coordinate with other workflows as necessary to ensure all safety information is captured accurately.
    • Act as a Subject Matter Expert (SME) for assigned projects, providing guidance and mentorship to junior team members, and assisting with training to enhance overall quality.

    Compliance and Training

    • Ensure timely completion of internal and external training programs.
    • Support and participate in audits, ensuring that CAPAs are addressed and closed on time.
    • Provide support for other MICC-related activities as required by the business.

    Desirable Skills and Experience

    • 1-3 years of experience in a MICC role or similar pharmacovigilance-related field.
    • Graduate or post-graduate degree in Life Sciences or a related field.
    • Strong communication skills for effective client communication and coordination within a cross-functional team.
    • Ability to maintain a detail-oriented approach and demonstrate strong organizational skills.
    • Ability to work effectively in a fast-paced environment while adhering to strict timelines and quality standards.

    Why Join Us?

    This is a fantastic opportunity to begin or advance your career in Pharmacovigilance and Medical Information while supporting critical safety processes. You’ll have the chance to work in a dynamic, collaborative environment where your contributions make a real impact on patient safety and product compliance.

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