Bioclinica Hiring Pharmacovigilance Sr. Drug Safety Associate

Bioclinica Hiring Pharmacovigilance Sr. Drug Safety Associate
  • Full Time
  • Anywhere
  • ₹350000 - 500000 INR / Year
  • Mysore
  • Postal Code: 570016
Region: Mysore

Bioclinica Hiring Pharmacovigilance Sr. Drug Safety Associate

Location : Mysore, India

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.

Working Conditions: Normal office environment.

Hours:

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

Apply Now 

To apply for this job please visit clarioclinical.wd1.myworkdayjobs.com.

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