For almost 50 years, we have led the way in delivering better clinical evidence with our clinical research data management services. In that time, our technology, expertise and know-how have helped more than 800 new drugs come to market.
Post : Drug Safety Associate I
Job Description :
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.
Candidate Profile :
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 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.
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.
Additional Information
Location : Mysore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Drug Safety
End Date : 30th June, 2022
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