The PV Validation Analyst will ensure that pharmacovigilance systems and processes meet regulatory standards through thorough computer system validation (CSV). This includes creating and reviewing validation documents and collaborating with teams to meet GxP and regulatory requirements.
Responsibilities
- Create and review validation documentation: Develop validation plans, protocols, and reports for CSV activities.
- Ensure compliance: Validate pharmacovigilance systems in accordance with 21 CFR Part 11 and EU Annex 11 requirements.
- Problem-solving: Identify and address issues related to PV systems with minimal supervision.
- Project management: Manage multiple tasks efficiently while adhering to deadlines.
- Collaboration: Work closely with various departments to ensure smooth validation processes.
Required Qualifications
- Education: Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field.
- Experience: 3 years of experience in Computer System Validation (CSV) within pharmacovigilance or the pharmaceutical industry.
- Regulatory Knowledge: Strong understanding of 21 CFR Part 11 and EU Annex 11 requirements.
- Skills:
- Ability to create, review, and manage validation documentation.
- Strong attention to detail and ability to work independently.
- Problem-solving abilities with the capacity to juggle multiple tasks.
- Excellent communication and interpersonal skills.
Preferred Qualifications
- Experience with PV systems: Familiarity with tools like Argus, ArisGlobal, or other similar software.
- Risk management expertise: Ability to implement mitigation strategies in CSV activities.
- GxP Knowledge: Understanding of GxP regulations within a pharmacovigilance context.
