Pharmacovigilance (Principal) Specialist - Audits and Inspections

Are 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:
• Driving the audit and inspection processes and ensuring they are following regulatory expectations and best practice
• Trending Pharmacovigilance related findings on ongoing basis and proactively communicating trends to management and stakeholders
• Providing support and advice to the organisation in data privacy related matters 
• Advisory role in PV compliance related matters

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:
• A master’s degree in life sciences (e.g. pharmaceutical or medical science etc.) and an expert knowledge of pharmacovigilance principles and regulatory requirements
• Broad hands-on experience within pharmacovigilance domain and preferably experience in co-ordinating and handling audits and inspections
• Knowledge of GCP and GMP requirements including GxP documentation
• Strong quality mindset, ability to focus on details and adherence to standards, while maintaining a balanced oversight and high-level business perspective
• Professional proficiency in English

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

In QPPV Office we are around 50 colleagues with different professional background divided into different departments ensuring maintenance of PV oversight and compliance and support to the QPPV and deputy QPPV in Novo Nordisk, Global Safety, and affiliates worldwide.

The primary responsibilities of the teams are coordination of PV Audits and Inspections and PV regulatory surveillance and external affairs, tracking of compliance and quality of Individual Case Safety Reports (ICSRs), maintaining Pharmacovigilance System Master File (PSMF), handling Safety Data Exchange Agreements (SDEAs) and integration of new assets, support to HQ functions and affiliates in handling of safety in Patient Support Programs (PSPs)/Market Research Programs (MRPs) and Digital Health initiatives as well as developing & maintaining digital applications for safety data analysis.