Clario (Bioclinica) Pharmacovigilance Drug safety Associate Job Openings India

Clario Pharmacovigilance Drug Safety Associate I Job Openings in India. interested & Eligible Candidates apply Now

locations : Mysore, India
type : Full time

Essential Duties and Responsibilities:

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.

Clario (Bioclinica) Pharmacovigilance Drug safety Associate Job Openings India
Clario (Bioclinica) Pharmacovigilance Drug safety Associate Job Openings India

3 thoughts on “Clario (Bioclinica) Pharmacovigilance Drug safety Associate Job Openings India”

  1. Ms. Pritam Ramdas Galande

    Hello sir / madam,
    I have completed b pharmacy. I’m looking for a job in medical coding. I have achieved 2 month training in medical coding.
    I can join immediately. I give my best for these organization .

  2. Hello sir my name is komal shinde
    I have done b.pharmacy in dec 2020
    Sine in have been working as clinical Quality assurance executive
    I’m looking for job opportunity for pv
    Please give me opportunity i will do my best

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