QA and Pharmacovigilance Manager
Join Mundipharma's Nordic Team as Quality & Pharmacovigilance Manager.
Your new company
Mundipharma Nordics is part of Mundipharma/Napp/Purdue – an international network of independent associated pharmaceutical companies. The Nordic regulatory affairs department at Mundipharma is responsible for registration of the company’s products in Denmark, Sweden, Norway, Finland and Iceland. Mundipharma Nordics has implemented a new growth strategy and is now focusing on the acquisition of new products, late stage, phase III, registration status or already launched products. In 2018, a number of new products will be launched in the Nordic Region. Mundipharma Nordic employ approx. 75 employees and maintains offices in Denmark, Sweden, Norway and Finland.
We are looking for a highly professional, committed and motivated QA and Pharmacovigilance Manager for Denmark and Iceland. As a QA and Pharmacovigilance Manager, you will join our Nordic team in either Vedbæk, Denmark or Gothenburg, Sweden. The position is reporting to the Head of Nordic Regulatory Affairs, Pharmacovigilance and Quality, Denmark.
Your new role
- Act as QA Responsible Person (RP) in Denmark and Iceland
- Responsible for audits and inspections in Denmark and Iceland
- Ensure that QA and PV activities on a Nordic level are performed in compliance with current GxP, national and EU-regulations
- Surveillance of GDP and PV legislation and guidelines and implementation of required changes
- Ensure relevant processes for the Quality Management System (QMS) are implemented and maintained
- Responsible for deviations/CAPAs and change control in Denmark and Iceland as well as secure necessary corrective measures are put in place
- Maintenance of Mundipharma´s wholesale dealer’s authorisation and the authorisation to handle euphoriant substances.
- Act as deputy for QPPV in Nordic countries
- Responsible for product complaints and recalls in Denmark and Iceland
- Ensure relevant conditions on a Nordic level are in place to accommodate both internal European demands and authorities’ requirements for QA and PV
- Ensure relevant processes for QA, PV and Complaint handling are implemented and maintained
- Involved in review and approval of quality agreements regarding outsourced GDP activities
- Support in ad hoc QA and PV tasks within Quality and Drug Safety
What you'll need to succeed
You hold a Master of Science in Pharmacy or equal relevant education in Life Sciences, combined with 2-3 years’ practical experience working in a GxP environment (especially with quality assurance) from the pharmaceutical industry or Health Authority. Furthermore, you have experience from a QA RP role and experience with audits as well as understanding of the Pharmacovigilance area.
In order to succeed in the job, it requires that you are quality and detail-oriented, able to prioritize and manage multiple tasks within deadlines and at the same time able to embrace the broad perspective. You are a team player with a positive and service minded attitude, have good communication and interpersonal skills as the job involves plenty of contact and support to other colleagues and health authorities in the Nordic countries.
Furthermore, you have excellent written and verbal communication skills in English as well as Danish (or Swedish or Norwegian) – and have a flair for IT systems. Some travel activity may be expected.
What you'll get in return
A challenging position in an international organization with a relaxed and friendly atmosphere where you will have the possibility to have an influence on further developing the Quality and Safety area at Mundipharma Nordics. Competitive salary incl. pension scheme and health insurance.
What you need to do now
The recruitment process is carried out in collaboration with Hays Specialist Recruitment. Please submit your application no later than 18th of June 2018. Review of applications and interviews will be conducted on an on-going basis. Your application will be handled with confidentiality.
If you have any questions please do not hesitate to contact Recruitment Consultant Céline Konrad at +45 29368816.
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