Senior Manager Inspection & Audit Readiness

ZipRecruiter; Dalkeith; On-site; GBP 45,000 - 70,000; Full time

Job summary

A leading company in the healthcare industry is seeking a dedicated professional for a specialized role in pharmacovigilance. This position involves managing audit readiness, coordinating inspections, and supporting regulatory initiatives. The ideal candidate will have a life sciences degree, strong knowledge of pharmacovigilance processes, and communication skills to guide teams through regulatory requirements.

Qualifications

• Experience in a Clinical Safety Department or related areas.
• Knowledge of global regulations for Pharmacovigilance and Device Vigilance.
• Fluency in English; knowledge of other languages is desirable.

Responsibilities

• Coordinate central pharmacovigilance input for inspections.
• Manage audits and inspection readiness.
• Deputise for the Global Head in reviewing regulatory requirements.

Skills

Fluency in English

Knowledge of global regulations for Pharmacovigilance

Understanding of pharmacovigilance/device vigilance processes

Education

Life science degree

Job description

Job Description

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.

Summary: Responsible for management and coordination of global GVP/GCP inspection & audit participation, conduct of global PS&PV self-assessments, and contribution to review of draft, new, and changed pharmacovigilance/device vigilance regulatory requirements.

About the Role

Major accountabilities:

• Coordinate central pharmacovigilance subject matter expert input and preparation for GVP or GCP inspections, EMA or other regulatory agency inspections.
• Establish and maintain communication channels (SharePoint, Teams) for inspection preparation.
• Provide guidance to SMEs on expectations and content delivery.
• Review inspector requests and ensure timely responses.
• Maintain SME list.
• Assess inspection observation impacts for vigilance partners.
• Notify pharmacovigilance community in Novartis about upcoming inspections.
• Coordinate and manage audits and audit readiness at central sites, including response development.
• Manage 1QEM for assigned audits.
• Assess audit observation impacts for vigilance partners.
• Gather insights from audits to facilitate lessons learned and self-assessment targets.
• Support mentoring for effective audit and inspection readiness in global ESPs supporting pharmacovigilance activities.
• Support global PS&PV self-assessment facilitation and management.
• 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.

Minimum Requirements:

• Life science degree.
• Fluency in English; knowledge of other languages desirable.
• Experience in a Clinical Safety Department or related areas such as Clinical Development.
• Knowledge of global regulations for Pharmacovigilance and Device Vigilance.
• Understanding of pharmacovigilance/device vigilance process inter-relationships.

Why Novartis:

Helping people with disease and their families takes 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 about our people and culture.

Commitment to:

Building an outstanding, inclusive work environment and a diverse team that reflects the patients and communities we serve.

Join our Novartis Network:

If this role isn't the right fit, sign up to our talent community to stay connected and learn about future opportunities: https://talentnetwork.novartis.com/network.

Benefits and Rewards:

Read our handbook to learn about how we support your personal and professional growth: https://www.novartis.com/careers/benefits.

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