Principal Pharmacovigilance Specialist – Audits and Inspections
Novo Nordisk
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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Principal Pharmacovigilance Specialist – Audits and InspectionsCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to assume a key coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and co-operating with many different stakeholders, at all levels of the organisation?If you find challenges like this exciting and inspiring, you may be our new (Principal) Specialist in the Qualified Person for Pharmacovigilance (QPPV) Office, Global Safety, Denmark driving the co-ordination and conduct of PV inspections and audits in HQ and support our affiliates globally.The position
As a Pharmacovigilance Specialist, you are primarily responsible for coordinating and supporting the activities related to PV audits and inspections in Global Safety and affiliates. This includes coordination of preparation, on-site support during the inspection, coordination of response preparation and submission to the Competent Authorities and timely closure of corrective and preventive actions (CAPAs).Strong collaboration with our stakeholders in Global Safety, Affiliates, Regulatory Affairs, Global Development and Corporate Quality and Audit function is essential for the role to ensure that the PV system is functioning properly, and we are always inspection ready.Your main responsibilities will be focused on:
You can make a great difference by further developing this area and serving as a role model for compliant behaviour.Since you will support the affiliates during PV inspections, you can expect some travel activity for onsite support, when needed.Qualifications
To be a competitive candidate, you should have:
As a person you are flexible and, highly motivated and visionary within the field of expertise, with the ability to work independently and drive your job responsibilities. You have robust analytical skills, demonstrated ability to adopt best practices and have proficient communication and coordination skills.You have a strong drive and can handle multiple complex tasks with often short deadlines. You are a team-player, have excellent cooperation skills, and are used to work with people who have very diverse professional and/or cultural background.
About the department Søborg, Hovedstaden
Sat, 04 May 2024 23:19:56 GMT
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