Content Review Practitioner

3 weeks ago

Bengaluru Karnataka, India Quess IT Staffing Full time

**About Us**

“Quess IT Staffing is India’s largest IT staffing company with over 20 years of experience in staffing IT professionals in 300+ companies across levels and skillsets. Our 10,000+ associates deployed in 80+ cities and towns are proficient in over 500 technological skills. Our associates help enable cutting edge solutions some of the biggest names across industried. Quess IT Staffing is a division of Quess Corp Limited, India’s leading business services provider and largest domestic private sector employer. Quess Corp Limited is - ‘A Great Place to Work’ certified - a testament to our excellent culture, people, and processes.”

**About Company**

**Roles and Responsibility**

Job title: Content Review Practitioner

Experience: Fresher

Notice period: Immediate to 15 days

Location: Bangalore

JD:

- Prioritize case processing activities for ICSRs in accordance with project guidelines, Regulatory due date and TAT SLAs and KPIs.
- Processing and evaluation of Individual Case Safety Reports Consistent data entry and processing from source documents, adhering to timelines and quality.
- Confirm accurate and consistent coding of medical history, drugs and adverse event terms.
- Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting the Medical Reviewer whenever needed.
- Alert the Medical Reviewer of potential safety issues and assist the Medical Reviewer in monitoring the safety profile of product as appropriate.
- Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Project SOP.
- Archive all communications/clarifications related to the Case in the Global Safety Database. Initiate and handle case deletions/ nullification as appropriate.
- To participate in audits or inspections.
- Open to get trained and moved across roles based on business requirement.
- Training and mentoring to new associates.
- Authoring of process documents.
- Minimum of Bachelor’s degree in Health Sciences; Bachelor’s Degree in Life Science with relevant Pharmacovigilance experience.
- Knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
- Good medical writing skills
- Good Communication Skills
- Analytical Ability
- Strong English Language proficiency
- Validate research related to medical Fields/Products, and audit the receipt of the cases to analyze their seriousness, and based on their observation & upload the data in a tool specifically based on the defined guidelines of the client.
- Validate the research related to medical Fields/Products.

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