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    Junior Micc Associate

    Navitas Life Sciences
    1+ years
    Not Disclosed
    Bangalore Bengaluru
    10 April 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    We are currently seeking a Junior MICC Associate to join our growing team.

    Working within the Medical Information Contact Centre (MICC) for the Pharmacovigilance function you will:

    •  Follow both global and local regulations to protect personal and client related data as per company policy.
    •  Be responsible for receiving calls/Email (AE, PQC, MI & GI), case intake, duplicate check, and registration
    •  Follow up Inquiry through phone, email including translation of inquiry if not in a primary language (English)
    •  Be required to always exhibit a detail-oriented etiquette and friendly attitude when answering telephone calls.
    •  Ensure that calls are appropriately escalated to supervisor when necessary
    •  Ensure timely completion of internal/external training as and when assigned
    •  Participate/Support in Audits and responsible for closing CAPAs on time
    •  Provide support in other MICC related activities as per the business requirement.

    Within the role you will be responsible for the following:

    Individual Case Safety Report

    •  Data entry of individual case safety reports (all case repost types) into the safety database
    •  Review and evaluate AE case information to determine required action based on, and following, internal policies and procedures
    •  Process all cases to meet timelines as per prioritization with defined quality and productivity to meet project SLAs and KPIs
    •  Coding all medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
    •  Writing and/or checking for correctness and completeness of the medically relevant safety narrative in chronological order
    •  Checking the completeness and accuracy of the data entered in the various fields
    •  Source document preparation and archival, as required
    •  Perform necessary changes in the demoted/back routed cases from Quality reviewer/Medical reviewer
    •  Review the QR feedback received and, if necessary, ensure that the feedback comments are addressed
    •  Co-ordinate with other workflows as required
    •  Act as a Subject Matter Expert for assigned projects, providing review feedback, mentoring, and training team to enhance quality

    Desirable Skills and Experience

    •  1-3 years of experience in an MICC role
    •  Graduate or post graduate degree in life sciences
    •  Strong communication skills for effective client communication and coordination

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