Computer system validation Lead / Senior Validation associate

**Job Description:**

As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited to Argus, ArisG, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems.

**Key Responsibilities:**
- Lead validation efforts for drug safety systems such as Argus, ArisG, or other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations).
- Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matrices.
- Perform risk assessments and impact analysis of software changes or upgrades to ensure compliance with validation requirements.
- Collaborate with cross-functional teams (IT, Quality Assurance, Pharmacovigilance, and Compliance) to ensure effective implementation and maintenance of validated systems.
- Provide guidance and training on validation processes and regulatory requirements.
- Support audits and inspections related to CSV activities and respond to findings or inquiries from regulatory bodies.
- Manage the CSV lifecycle, including requirements gathering, testing, and system releases for safety systems.
- Ensure that all system-related issues are identified, tracked, and resolved in a timely manner.

**Qualifications:**
- Bachelor's degree in Computer Science, Life Sciences, or a related field (or equivalent experience).
- Minimum of 5 years of experience in Computer System Validation, with a focus on drug safety systems (Argus, ArisG, or similar).
- In-depth knowledge of pharmaceutical and regulatory requirements, including 21 CFR Part 11, GxP, and ICH guidelines.
- Strong experience in system validation and lifecycle management of computer systems, including testing, documentation, and quality assurance processes.
- Familiarity with the pharmacovigilance domain and the processes for adverse event reporting and management.
- Excellent communication and leadership skills with the ability to work in cross-functional teams.
- Experience with audit readiness and regulatory inspections (FDA, EMA, etc.) is a plus.
- Certification in Computer System Validation or related fields is a plus.