Essential Duties and Responsibilities:

As Quality Check Reviewer

  • Review data entered in safety database for completeness and accuracy.
  • Provide quality feedback to team resources
  • Track and maintain quality metrics

    As Case Processor

  • Responsible for data entry of Individual case safety reports into the safety database.
  • Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
  • Process all incoming cases in order to meet timelines.
  • Full data entry including medical coding and safety narrative.

    As Medical Coder

  • Responsible for 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).

    As Narrative Writer

  • Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

    Other responsibilities:

  • Following up with sites regarding outstanding queries.
  • Follow up on reconciliation of discrepancies.
  • Follow departmental AE workflow procedures.
  • Closure and deletion of cases.
  • Mentor and guide the activities of the Dug Safety Associate.
  • High level of proficiency al all workflow tasks.
  • Perform any other drug safety related activities as assigned.

Specialized knowledge and skills:

  • Basic competence with medical and therapeutic terminology.
  • Ability to work independently but guided by documented procedures, with appropriate support.
  • Able to work effectively as part of a team.
  • Understanding of patient safety regulatory obligations.
  • Should be familiar with regulatory &pharmacovigilance guidelines.
  • Should be familiar with pharmacovigilance terminology.
  • Excellent attention to detail.
  • Ability to deliver within established timelines.
  • Fluency in English and excellent comprehension.
  • Computer literate.
  • Relevant product and industry knowledge.
  • Experience with relevant software applications.

    Communication skills:

  • Requires a proactive approach and excellent written/oral communication and interpersonal skills.
  • Strong interpersonal skills required to interact with clients, management, and peers effectively.
  • Effective cross‑department communication.
  • Ability to document and communicate problem/resolution and information/action plans.

    Desired technical skills:

  • Person should be familiar with MS Office Tools.
  • Safety database knowledge.

    Other skills:

    The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.

    Compliance:

    Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.

    Working Conditions: Normal office environment.

    Hours:

    Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.

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