Company Overview

Pharmazone 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 Overview

Exciting 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

• 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