Bioclinica – Urgent job openings for Drug Safety Professionals | Apply Now

Bioclinica India is hiring experienced Drug Safety professionals for ICSR Case processing.
The work location is Mysore.
The title will commensurate with experience and company policy.
Post Name: Drug Safety Professionals
Qualification : Must be a graduate in Pharmacy (B Pharmacy, M Pharamcy, Pharm D, BDS)
Experience : Minimum 1 to 3 years experience in ICSR case processing.
Job Location: Mysore
Primary 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
  • Understanding of Patient Safety regulatory obligation
  • Good attention to detail
  • Ability to deliver within established timelines
  • Fluency in Spoken and written English and excellent comprehension

Additional Skills

  • Strong motivational skills and abilities, promoting a team-based approach
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal-oriented
  • Ability to maintain professional and positive attitude

Click here to Apply Online

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