Global Safety Compliance Specialist within Audits & Inspections - Denmark
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- Are you ready to assume a coordinating role for planning, conduct and follow-up on PharmacoVigilance (PV) audits and inspections?
- Is it working independently with a high degree of flexibility and responsibility whilst influencing and interacting with many different types of people at all levels of the organisation what you are looking for?
- If you find challenges like these 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 primary responsibilities of the Global Safety Compliance department are coordination of PV Audits and Inspections, Individual Case Safety Report (ICSR) Compliance Tracking, Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance, and support to HQ functions and affiliates in safety handling of Patient Support Programmes and Market Research Programmer.
- We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance, Global Safety and affiliates worldwide.
- You are accountable for coordinating and supporting the activities related to PV audits and inspections in Global Safety and affiliates, which includes coordination of audit/inspection preparation, on-site support during the inspection, and coordination of response preparation and submission to the Competent Authorities.
- You will drive the audit and inspection processes in Global Safety and ensure they are in compliance with regulatory expectations and follow best practice at all times.
- You are expected to perform trending and analyses of PV related findings on a continuous basis and proactively communicate trends to relevant stakeholders including management.
- Strong collaboration with our stakeholders in Global Safety, Affiliates, Regulatory Affairs, Global Development and Corporate Quality among others is essential for the role to ensure that the quality system is functioning properly and we are inspection ready at all times.
- Ensuring safe products and compliance is at the heart of company's business.
- By being part of further developing this area and serving as a role model for compliant behavior, you can make a great difference.
- Since you will support the affiliates during PV inspections, you can expect some travel per year.
- You hold a Master’s degree with a scientific background e.g. Chemistry, Biology, and Pharmacy.
- 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, ability to find trends and patterns in data, and can interpret data and integrate and communicate information into a sound conclusion.
- You have 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 orientation, including the ability to focus on details and adherence to standards, while maintaining a balanced business perspective.
- You are fluent in both written and spoken English on a specialist level.
Working with Us:
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.