Kinapse

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

Associate (PV)

Updated: May 25, 2021
Location: Gurgaon, HR, India
Job ID: 131204


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Overview

Do you want to work in an environment and culture where you can thrive, develop and advance?

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Responsibilities

Management of duplicate ICSRs/Cases

  • Assessment of potential duplicate ICSRs/Cases
  • Creation of Master case for underlying duplicate ICSRs/Cases in database (including narrative writing, drug coding, MedDRA coding, lab data, medical history and other relevant fields)
  • Update of existing Master Cases based on follow-up information received for underlying ICSRs/Cases in database
  • Raising follow-up to obtain clarification or missing information
  • Analyse and respond to queries related to potential duplicate ICSRs/Cases

xEVMPD validation (or quality review of xEVMPD records)

  • Validation (review or quality control) of xEVMPD product records against source documents (SmPC, PIL, MA letter)
  • Correction of underlying data based on validation findings – including MedDRA coding of indications, drug coding and other relevant fields
  • Raising follow-up to obtain clarification or missing information
  • Analyse and respond to queries related to xEVMPD data
  • Analyse complex product data in excel or tables

Job Requirements

Management of duplicate ICSRs/Cases

  • Designation: Associate
  • Qualification: M.Pharmacy
  • Good written and verbal communication skills (command of English equivalent to level of B2 of the CEFR)
  • Minimum 2 years of experience in Pharmacovigilance and ICSR case processing
    • ICSR case processing (or data entry / quality review of ICSRs), MedDRA coding, drug coding, narrative writing
    • Experience of working on safety database like Argus, ARISg, Eudravigilance

 

xEVMPD validation (or quality review of xEVMPD records)

  • Designation: Associate
  • Qualification: M.Pharmacy
  • Good written and verbal communication skills (command of English equivalent to level of B2 of the CEFR)
  • Good excel skills
  • Minimum 2 years of experience in handling xEVMPD data
    • Population or review of xEVMPD data in product database from SmPC and other source documents (PIL/MA letter) – including MedDRA and drug coding
  • Experience of working on product database like RIMS, xEVMPD / Article 57 database

We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion


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