Senior Manager Inspection & Audit Readiness

Senior Manager Inspection & Audit Readiness

Job Description Summary
Responsible for managing and coordinating global GVP/GCP inspection and audit participation, conducting global PS&PV self-assessments, and contributing to the review of draft, new, and revised pharmacovigilance/device vigilance regulatory requirements.

Job Description

Major accountabilities:

1. Coordinate central pharmacovigilance expert input and preparation for GVP or GCP inspections, EMA, or national inspections.
2. Establish and maintain communication channels (e.g., SharePoint, Teams) for inspection preparation.
3. Guide SMEs on expectations and content delivery.
4. Review inspector requests and ensure timely responses.
5. Maintain SME lists.
6. Assess inspection observation impacts for vigilance partners.
7. Notify pharmacovigilance community of upcoming inspections.
8. Coordinate and manage audits and ensure audit readiness at central sites, including response development.
9. Manage 1QEM for assigned audits.
10. Assess audit observation impacts for vigilance partners.
11. Aggregate insights from audits to identify lessons learned and support self-assessment targets.
12. Support mentoring for effective audit and inspection readiness within global ESPs supporting pharmacovigilance activities.
13. Assist in facilitating and managing global PS&PV self-assessments.
14. Deputize for the Global Head, I&AR, in reviewing draft, new, or revised pharmacovigilance/device vigilance regulatory initiatives, requirements, and guidelines. Conduct impact assessments for changes affecting audits and inspections when required.

Minimum Requirements:

• Degree in Life Sciences or related field.
• Fluency in English; knowledge of additional languages is desirable.
• Experience primarily in Clinical Safety or closely related areas such as Clinical Development.
• Knowledge of global regulations for Pharmacovigilance and Device Vigilance.
• Understanding of the inter-relationships within pharmacovigilance and device vigilance processes.

Why Novartis: Helping people with diseases and their families requires more than innovative science. It takes a community of smart, passionate people like you, collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients\’ lives. Learn more .

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment with a diverse team that reflects the patients and communities we serve.

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Skills Desired: Clinical Trials, Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Team Management, Waterfall Model.

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