17 Nov

Dsa Jobs Vacancy in Bioclinica Mysore

Position
Dsa
Company
Bioclinica
Location
Mysore KA
Opening
17 Nov, 2018 30+ days ago

Bioclinica Mysore urgently required following position for Dsa. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Dsa Jobs Vacancy in Bioclinica Mysore Jobs Details:

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 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.

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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