Jr. Drug Safety Associate

Shine (Mysuru, KA, India) 9 days ago

SkillSet: case processing, pharmacovigilance, safety, case, data entry.

Essential Duties and Responsibilities:

As Case Intake Member:

  • Responsible for case intake, duplicate check, and registration
  • Maintain log of source documents and other communications

    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.

    As Literature Review Specialist

  • Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
  • Review of literature articles to identify case safety reports.
  • Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
  • Assist in signal generation and safety analysis activities.
  • Ensure quality of literature searches and reporting.
  • Review of local/global literature reports to determine regional reportability.
  • Create/maintain study summary documents.
  • Assist with narrative writing for periodic/ad hoc submissions.
  • Assist with ad hoc or routine safety monitoring activities.

    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
  • 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 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.

    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.

    Willing to work in shifts as and when needed

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Jr. Drug Safety Associate

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