Job title: ICSR

Company: Pharmazone

Job description: Company OverviewPharmazone is a trusted Consulting company specializing in Regulatory Affairs, Pharmacovigilance, and GxP Compliance solutions for Pharmaceutical & Life Sciences industry. Award-winning with a commitment to improving patient lives through innovative solutions.Job OverviewExciting opportunity for an ICSR role at Pharmazone, a leading Consulting company in the Pharmaceutical & Life Sciences industry. Full-Time position in Ahmedabad, Gujarat, India. Salary range: Competitive. Employee count: 51-200.Qualifications and Skills

  • Experience: 1 to 3 years in ICSR and Pharmacovigilance
  • Proficiency in Clinical trial cases and Data entry processes
  • Knowledge of Drug safety guidelines and regulations
  • Strong attention to detail and accuracy in ICSR activities
  • Ability to work effectively in a team environment

Roles and Responsibilities

Business Development (Sales) part time job/internship at Surat in Auggin Technologies Private Limited
  • Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources
  • Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
  • Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
  • Responsible for identifying duplicate/invalid ICSRs
  • Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports
  • Perform data entry for all subject information into EDC databases as required
  • Perform peer review, quality review of cases as and when required
  • Perform peer review, quality review of all EDC data entered as required
  • Accountable for sending queries for clarity associated with incoming information if required
  • Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
  • Ensure that case narrative comprises correct and appropriate safety information
  • Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
  • Contributes to safety and pharmacovigilance training programs.
  • Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
  • Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
  • Training and mentoring of Pharmacovigilance Associates

Location: Ahmedabad, Gujarat

Job date: Tue, 19 Mar 2024 03:16:36 GMT