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reference: 4973381

documentId: 4973381

connectionPointId: 7

lastModificationDate: 1554899436093

stillingsbetegnelse:
Pharmacovigilance Compliance Specialist within Audits and Inspections in Global Safety

jobbeskrivelse:

Are you ready to assume a 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 interacting with many different types of people, at all levels of the organisation? If you find challenges like this exciting and inspiring, you may be our new Compliance Specialist, working within audits and inspections in Global Safety, Denmark and our affiliates globally.

 

About the department

The position is located in Global Safety Compliance, which is part of the QPPV Office under Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. 

The primary responsibilities of the Global Safety Compliance department are ICSR Compliance Tracking, Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance, coordination of PV Audits and Inspections, support to HQ functions and affiliates, including handling of safety in Patient Support Programs, Market Research Programs and Digital Health initiatives. We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk, Global Safety and affiliates worldwide.  

 

The job

You are accountable 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). You will drive the audit and inspection processes in the department and ensure they are following regulatory expectations and best practice. You will be expected to perform trending of PV related findings on a continuously basis and proactively communicate trends to management and relevant stakeholders. In addition, you will maintain and provide oversight of the PV training programmes for affiliates. 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 quality system is functioning properly, and we are always inspection ready. 

Ensuring safe products and compliance is at the heart of Novo Nordisk's business. 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 per year.

 

Qualifications

You hold a Master’s degree with a scientific background. You have extensive knowledge of PV principles and regulatory requirements, broad hands-on experience within PV from various positions, previous proven experience in audits and inspections, and at least general knowledge of GCP and GMP requirements including GxP documentation. 

You are open-minded, highly motivated and visionary within the field of expertise, with the ability to work independently and drive your job responsibilities. You have strong analytical skills and demonstrated ability to identify better practice and create improvements. You have a strong drive and are able to coordinate 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. 

The role requires a strong quality mind set, ability to focus on details and adherence to standards, while maintaining a balanced business perspective. You are fluent in both written and spoken English at a specialist level. 

The application should be written in English. 

At Novo Nordisk we use our skills, dedication and drive to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.

 

Contact

For further information, please contact Mette Stockner +45 30 75 69 38.

 

Deadline

22 April 2019 

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: NOVO NORDISK A/S

source: DK-STAR