PV Validation Analyst at 3Analytics
Experience: 3 Years
Salary: ₹4 – 8 Lacs Per Year
Location: Remote
Education: Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field
Why Join 3Analytics?
3Analytics is a forward-thinking company specializing in providing pharmacovigilance and validation services. As a PV Validation Analyst, you’ll play a critical role in ensuring that pharmacovigilance systems meet regulatory standards. Working with a remote team of experts, this position offers flexibility, work-life balance, and the opportunity to contribute to the safety and efficacy of pharmaceutical products. PV Validation Analyst at 3Analytics
Position Overview: PV Validation Analyst
The PV Validation Analyst will be responsible for conducting thorough Computer System Validation (CSV) activities to ensure compliance with regulatory requirements, including 21 CFR Part 11 and EU Annex 11. You will work closely with various teams to manage validation documentation, ensure compliance, and tackle issues within the pharmacovigilance (PV) systems. PV Validation Analyst at 3Analytics
Key Responsibilities
- Validation Documentation: Develop and review validation plans, protocols, and reports for CSV activities, ensuring that documentation is accurate and up to regulatory standards.
- Compliance Assurance: Ensure pharmacovigilance systems comply with 21 CFR Part 11, EU Annex 11, and other relevant regulations.
- Problem Solving: Identify issues related to PV systems and work independently to resolve them with minimal supervision.
- Project Management: Manage multiple validation tasks efficiently, meeting project deadlines without compromising quality.
- Collaboration: Work with cross-functional teams, including IT, quality assurance, and pharmacovigilance departments, to ensure seamless validation processes. PV Validation Analyst at 3Analytics
Required Qualifications
- Education: A Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field.
- Experience: A minimum of 3 years of experience in Computer System Validation (CSV) within the pharmaceutical or pharmacovigilance industry.
- Regulatory Knowledge: A strong understanding of 21 CFR Part 11 and EU Annex 11, with the ability to apply these regulations to PV systems.
- Skills:
- Expertise in creating, reviewing, and managing validation documentation.
- Strong attention to detail and the ability to work independently.
- Problem-solving skills, with the ability to handle multiple tasks efficiently.
- Excellent communication and interpersonal skills to collaborate with diverse teams.
PV Validation Analyst at 3Analytics
Preferred Qualifications
- PV System Experience: Familiarity with pharmacovigilance systems such as Argus, ArisGlobal, or similar tools is highly preferred.
- Risk Management: Expertise in identifying risks and implementing mitigation strategies during CSV activities.
- GxP Knowledge: Solid understanding of GxP regulations and their application within a pharmacovigilance context.
What We Offer
At 3Analytics, we offer a supportive and flexible work environment where your expertise will contribute to the success of innovative projects. You’ll have the opportunity to grow professionally, enjoy work-life balance, and work remotely with a team that values collaboration and innovation. PV Validation Analyst at 3Analytics
How to Apply
If you have the relevant experience and are ready to take on a challenging yet rewarding role in PV validation, we encourage you to apply!
Apply online to become a part of 3Analytics and make a difference in the world of pharmacovigilance and compliance.