Bioclinica Hiring Pharmacovigilance Sr. Drug Safety Associate

Location : Mysore, India

Essential Duties and Responsibilities:

As Quality Check Reviewer

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:

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

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