BIOCLINICA – Pharmacovigilance jobs 2021 | Drug Safety Associate II

BIOCLINICA

Hiring Drug Safety Associate ll

Job Location :- Mysore

Qualification :- all life sciences graduates

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. As Narrative Writer
MedDRA, Company Product Dictionary, WHO-DD).

Responsible for writing medically relevant safety

narrative of cases and checking the completeness and

accuracy of the data entered in the various fields.

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.

Fluency in English and excellent comprehension.

Computer literate.

Relevant product and industry knowledge.

Experience with relevant software applications.

Application process :-

Check out this job at Bioclinica: https://www.linkedin.com/jobs/view/2651925010

OR

https://bioclinica.wd1.myworkdayjobs.com/en-US/Bioclinica_careers/job/Mysore-India/Drug-Safety-Associate-II_R7822