Jr. Drug Safety Associate

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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