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- Tasks: Lead global inspections and audits in pharmacovigilance, ensuring readiness and compliance.
- Company: Join Novartis, a leader in innovative healthcare solutions dedicated to improving patient lives.
- Benefits: Enjoy a diverse work environment, flexible working options, and opportunities for personal growth.
- Why this job: Be part of a passionate team making a real impact on global health and safety.
- Qualifications: Degree in Life Sciences; experience in Clinical Safety or related fields required.
- Other info: Fluency in English is essential; additional languages are a plus.
The predicted salary is between 43200 - 72000 £ per year.
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.
Major accountabilities:
- Coordinate central pharmacovigilance expert input and preparation for GVP or GCP inspections, EMA, or national inspections.
- Establish and maintain communication channels (e.g., SharePoint, Teams) for inspection preparation.
- Guide SMEs on expectations and content delivery.
- Review inspector requests and ensure timely responses.
- Maintain SME lists.
- Assess inspection observation impacts for vigilance partners.
- Notify pharmacovigilance community of upcoming inspections.
- Coordinate and manage audits and ensure audit readiness at central sites, including response development.
- Manage 1QEM for assigned audits.
- Assess audit observation impacts for vigilance partners.
- Aggregate insights from audits to identify lessons learned and support self-assessment targets.
- Support mentoring for effective audit and inspection readiness within global ESPs supporting pharmacovigilance activities.
- Assist in facilitating and managing global PS&PV self-assessments.
- Deputise 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.
Skills Desired:
- Clinical Trials
- Databases
- Employee Training
- Pharmacovigilance
- Reporting
- Safety Science
- Team Management
- Waterfall Model
Senior Manager Inspection & Audit Readiness employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Inspection & Audit Readiness
✨Tip Number 1
Familiarise yourself with the latest global regulations for Pharmacovigilance and Device Vigilance. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the pharmacovigilance community. Engaging with others in the field can provide insights into the role and may even lead to referrals, which can significantly boost your chances of landing the job.
✨Tip Number 3
Prepare to discuss your experience with audits and inspections in detail. Be ready to share specific examples of how you've contributed to audit readiness or managed inspection processes, as this will be crucial for the Senior Manager role.
✨Tip Number 4
Showcase your leadership skills by highlighting any mentoring or training experiences you've had. This is particularly important for a managerial position, as the ability to guide and support others is key to success in this role.
We think you need these skills to ace Senior Manager Inspection & Audit Readiness
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Clinical Safety, Pharmacovigilance, and Audit Readiness. Use specific examples that demonstrate your expertise in managing inspections and audits.
Craft a Compelling Cover Letter: Write a cover letter that addresses the key responsibilities of the Senior Manager role. Emphasise your experience with GVP/GCP inspections and your ability to coordinate communication among teams.
Showcase Your Skills: In your application, clearly outline your skills related to Clinical Trials, Team Management, and Employee Training. Provide concrete examples of how you've applied these skills in previous roles.
Highlight Regulatory Knowledge: Demonstrate your understanding of global regulations for Pharmacovigilance and Device Vigilance. Mention any specific experiences where you contributed to compliance or regulatory initiatives.
How to prepare for a job interview at Novartis
✨Understand the Regulatory Landscape
Familiarise yourself with global regulations related to Pharmacovigilance and Device Vigilance. Being able to discuss recent changes or trends in these areas will demonstrate your expertise and commitment to the role.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to guide SMEs and coordinate teams effectively. Prepare examples of how you've successfully led teams or projects in the past, particularly in audit readiness or inspection preparation.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Think about past experiences where you had to manage audits or inspections and be ready to discuss the outcomes and lessons learned.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating your thoughts clearly, especially when discussing complex topics like GVP/GCP inspections. This will help you convey your ideas confidently during the interview.
