Are you looking for a career in pharmacovigilance with a focus on Individual Case Safety Reports (ICSR)? Vizen Life Sciences Pvt. Ltd. offers an exciting opportunity for professionals passionate about safety and compliance in the healthcare sector.
About Vizen Life Sciences Pvt. Ltd.
Vizen Life Sciences Pvt. Ltd. is a fast-growing organization specializing in pharmacovigilance services, regulatory compliance, and medical affairs. We are dedicated to ensuring drug safety through innovative and precise processes, contributing to better healthcare outcomes worldwide.
Key Responsibilities of the Role
1. Duplicate Search:
Perform comprehensive searches to identify and eliminate duplicate case entries, ensuring data accuracy.
2. Case Validity Assessment:
Evaluate submitted cases to verify completeness and relevance, ensuring adherence to company criteria and regulatory standards.
3. Coding of Suspect Products:
Utilize industry-standard dictionaries like CCD-ODD to accurately code suspect products.
4. Event Coding and Seriousness Assessment:
- Conduct MedDRA coding for adverse events.
- Assess and document the seriousness of cases following regulatory guidelines.
5. Case Book-In Process:
- Process cases from various sources, including spontaneous reports, E2B submissions, and literature references.
- Ensure all essential data fields are accurately completed while adhering to company procedures and timelines.
Preferred Qualifications
Experience:
1-3 years of relevant experience in pharmacovigilance, specifically in ICSR Book-In processes.
Education:
- B.Pharm, M.Pharm, or Pharm.D.
Key Skills and Knowledge
- In-depth understanding of pharmacovigilance regulations and guidelines.
- Proficiency in ICSR book-in requirements, tools, and systems.
- Expertise in quality assurance and compliance protocols.
- Exceptional attention to detail, accuracy, and efficiency.
- Strong problem-solving and decision-making abilities.
- Effective communication and coordination skills.
Work Details
- Work Mode: 100% Work From Office.
- Work Schedule: Alternate Saturdays are working days.
