Are you a seasoned professional in Pharmacovigilance (PV) looking for a challenging role in Quality Review and Regulatory Report Submissions? Vizen Life Sciences Pvt Ltd is hiring for a full-time position! 🚀
About the Role 📝
As a Quality Review & Regulatory Report Submission Specialist, you’ll play a critical role in ensuring compliance with regulatory requirements and maintaining the company’s reputation for quality and excellence. You’ll work closely with cross-functional teams to ensure timely and accurate submission of regulatory reports.
Key Responsibilities 📚
- Regulatory Report Submission: Approve and schedule reports in the Argus database for submission to respective Health Authorities.
- Case Submission: Submit cases to Health Authorities, Business Partners, and Affiliates as required.
- Timeline Management: Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance.
- Quality Assurance: Schedule and approve regulatory reports based on reporting obligations.
Requirements 📝
- Experience: 4-6 years of relevant experience in Pharmacovigilance (PV), specifically in ICSR Quality Review and Regulatory Report Submissions.
- Argus Database Experience: Hands-on experience with the Argus Database is essential.
- Educational Qualification: B.Pharm/M.Pharm
- 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, and strong communication and time management abilities.
What We Offer 🌟
- Career Growth: Opportunities for professional development and growth in a dynamic and innovative company.
- Collaborative Team: Work with a team of experienced professionals who are passionate about Pharmacovigilance and Regulatory Affairs.
- State-of-the-Art Infrastructure: Work in a modern facility with cutting-edge technology and infrastructure.
How to Apply 📧
If you’re interested in this exciting opportunity, apply Now 👇🏻:
https://vizenlifesciences.keka.com/careers/jobdetails/57429
Tips for Quality Review & Regulatory Report Submission Specialists 📝
- Stay Current: Stay up-to-date with the latest developments and trends in Pharmacovigilance and Regulatory Affairs.
- Develop Strong Analytical Skills: Improve your analytical skills to effectively review and submit regulatory reports.
- Build a Strong Network: Network with professionals in the industry to learn from their experiences and stay informed about new opportunities.
Benefits of Working at Vizen Life Sciences Pvt Ltd 🌟
- Opportunity to Work with a Dynamic Team: Collaborate with a team of experienced professionals who are passionate about Pharmacovigilance and Regulatory Affairs.
- Professional Development and Growth: Opportunities for career growth and professional development in a rapidly growing company.
- State-of-the-Art Infrastructure: Work in a modern facility with cutting-edge technology and infrastructure.
