Quality Review and Submissions (ICSR)

Vizen Life Sciences; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Vizen Life Sciences seeks a Quality Review and Submissions professional specializing in ICSR PV. You will manage PV reporting to Health Authorities using the Argus database, ensuring compliance with timelines and regulatory obligations.

Key strengths include PV regulations knowledge, QA expertise, and strong attention to detail, with solid analytical and communication skills to coordinate with partners and affiliates.

Qualifications

• Strong knowledge of PV regulations and guidelines for Health Authority submissions.
• Expertise in quality assurance and compliance.
• Excellent attention to detail and analytical skills.
• Strong communication and time management abilities.

Responsibilities

• Approve and schedule reports in the Argus database for submission to Health Authorities as applicable.
• Submit cases to Health Authorities, Business Partners, and Affiliates as required.
• Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance.
• Schedule and approve regulatory reports based on reporting obligations.

Skills

PV regulations

Quality assurance

Attention to detail

Analytical skills

Communication

Time management

Tools

Argus Database

Job description

Quality Review and Submissions (ICSR)

Key Responsibilities

• Approve and schedule reports in the Argus database for submission to respective Health Authorities, as applicable.
• Submit cases to Health Authorities, Business Partners, and Affiliates as required.
• Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance.
• Schedule and approve regulatory reports based on reporting obligations

Job Requirement

Pharmacovigilance (PV), specifically in ICSR Quality Review and Regulatory Report Submissions

Hands-on experience with the Argus Database is essential.

Skills and Competencies:

• Strong knowledge of PV regulations and guidelines for Health Authority submissions.
• Expertise in quality assurance and compliance.
• Excellent attention to detail and analytical skills.
• Strong communication and time management abilities.