9) BIOCLINICA Fresher Pharmacovigilance Job Vacancies | Drug Safety Associate | Mysore

Bioclinica Pharmacovigilance Job Recruitment notificatio For Fresher Candidates 


JOB DESCRIPTION

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 uracy 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 establish 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
Application process :- Check out this job at Bioclinica: https://www.linkedin.com/jobs/view/2499156554
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