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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