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

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Apr 24, 2021

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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