Drug Safety Associate I Jobs in Mysore - Bioclinica

Drug Safety Associate I

Bioclinica

0 to 3 Years

Not disclosed

Expired

Posted: 14 Dec 20

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 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.
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.
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 crossâdepartment 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.

Other Skills

The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.

Compliance

Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.

Working Conditions: Normal office environment.