Associate Safety Case Reviewer

TransPerfect Inc; Pune District; On-site; INR 600,000 - 800,000; Full time

Job summary

TransPerfect Inc. in India seeks an Associate Safety Case Reviewer to support Pharmacovigilance Solutions Production in analyzing safety data and reporting in line with client requirements.

You will contribute to adverse event analysis, safety reporting to health authorities, GDP-compliant documentation, and cross-functional collaboration to mitigate risk.

Qualifications

• Knowledge of CTC and MedDRA coding.
• Familiarity with GCP, GDP and ICH guidelines.
• Proficiency with Word, PowerPoint, Excel, Outlook, EndNote, and databases like PubMed/Embase.

Responsibilities

• Analyze adverse events and safety data per client requirements.
• Prepare safety reports for health authorities.
• Maintain data integrity and GDP audit compliance.
• Adhere to timelines; communicate with Team Lead and Project Managers.
• Follow SOPs and governing guidelines.
• Review stakeholder safety complaints and mitigate risk with PMs.
• Perform other tasks as assigned.

Skills

CTC MedDRA coding

GCP GDP ICH guidelines

Office & scientific databases

English communication

Cross-functional collaboration

SOP compliance

Tools

EndNote

PubMed Embase

Job description

OVERVIEW

The Associate Safety Case Reviewer collaborates with the Pharmacovigilance Solutions Production team to analyze and report on safety parameters within the context of patient safety against our clients’ products, and in line with client requirements for case review.

DESCRIPTION

• Perform various tasks in support of our clients’ clinical research including: adverse event analysis and processing
• Prepare safety reports for submission to various health authorities
• Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards
• Adhere to project timelines, with proactive communication with Team Lead and Project Managers, as needed
• Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs)
• Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with Project Managers to mitigate risk and implement/drive solutions
• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

REQUIRED SKILLS

• Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding
• Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International Conference on Harmonization (ICH) guidelines
• Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc.
• Excellent written and oral communication skills in English
• Ability to work in collaborative, cross-functional teams
• Ability to meticulously review and validate work to ensure strict compliance with SOPs and client specifications