Associate Safety Case Reviewer
Associate Safety Case Reviewer
TransPerfect
Job description
Are you keen to work in pharmacovigilance and patient safety? Explore the Associate Safety Case Reviewer post at TransPerfect in Pune.
Company Overview
TransPerfect is a global provider of language and AI solutions to enterprises. Established in 1992, the company offers organisations multilingual services, technology and specialist skills. It has offices all over the world and delivers services in more than 200 languages to clients throughout the globe.
Job Overview
This is a full-time permanent role based out of Pune. This is a part of the Medical Writing function of TransPerfect and is responsible for pharmacovigilance case evaluation. The Associate Safety Case Reviewer will provide support to clinical research activities by reviewing and processing adverse events, generating safety reports for health authorities and ensuring data integrity in accordance with Good Documentation Practice standards. The function requires fulfilling project deadlines, following SOPs and relevant guidelines and liaising with Team Leads and Project Managers on safety related issues.
Main Responsibilities
Perform adverse event analysis and processing in support of clinical research operations.
Follow project schedules.
Perform given work in accordance with applicable conventions, divisional standards, templates and Standard Operating Procedures (SOPs).
Review stakeholder complaints on safety reporting, handle issues in real time and collaborate with Project Managers to manage risks and execute suitable remedies.
Other duties as given by Manager or Supervisor.
Qualification
Bachelor’s degree in a relevant discipline.
Required Skills
Should know Common Toxicity Criteria (CTC), and/or MedDRA coding.
Should know Good Clinical Practice (GCP), Good Documentation Practice (GDP) and ICH recommendations.
Knowledge of Microsoft Word, PowerPoint, Excel and Outlook.
Proficiency in EndNote and scientific databases like PubMed and Embase.
Follow SOPs accurately and fulfil the specific client requirements.
Salary
The average salary of an Associate Safety Case Reviewer in India is between ₹6 Lakhs and ₹8 Lakhs per annum.
Career advancement
This role can allow professionals to improve their knowledge of pharmacovigilance, adverse event processing, safety reporting, regulatory guidelines, documentation procedures and cross-functional project collaboration.
How to Apply
Check out our employment portal for the Associate Safety Case Reviewer role.
Click on the listing to get the full job details.
Enter your information and upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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