We are strengthening our organization and recruiting a Drug Safety Manager/QPPV.
As our Drug Safety Manager and QPPV you will be responsible for oversight of the PV system to ensure compliance and continuous inspection readiness. You will also work closely together with clinical operational staff, CROs and PV Service providers in the planning and execution of clinical trials and post marketing pharmacovigilance. You will also responsible for Safety Management Plans and Safety Data Exchange Agreements and provide input to (S)AEs (CIOMS), PSURs, DSUR, protocols, reports as well as Risk Management Plans and submission documents. You will report to the VP of Clinical & Regulatory Development and Pharmacovigilance and be part of a small team at Camurus working with Drug Safety and Pharmacovigilance tasks in collaboration with external service providers.
The position is based at Camurus Headquarters in Lund.
To be successful in this position you have a relevant university degree and minimum 5 years experience working within Safety and Pharmacovigilance in the pharmaceutical industry. You need to be familiar with local, European and global PV legislation/regulations. You have excellent oral and written communication skills in English and are motivated by working both independently and in a dynamic team environment. You are able to attend to details and enjoy handling multiple tasks, sometimes under high workload. As a person you are enthusiastic with a strong drive and have a solution-oriented mindset and hands-on work approach. You have an interest in and ability to work smart in close cooperation with the PV service provider to make the pharmacovigilance system function well.
The opportunity for you
This is a great time to join a highly dynamic company during a very exciting phase of growth. The position offers a truly international work environment and a dynamic corporate culture, with the possibility for individual development and growth.
Camurus has 110 employees with the global headquarters based in Lund. The corporate culture is driven by innovation, strong internal and external collaboration, ownership by everyone, quality, and passion for realizing challenging ideas and goals.
The application process is ongoing, so apply as soon as possible, we will be reviewing incoming applications on an ongoing basis. In this recruitment we are working with K2 Search as our recruitment agency. Please contact Senior Consultant Arne Nordström, +46 70 6989200 or Research Consultant Linnea Lindroth, +46 765 253859. All information with be handled with strict confidentiality. Apply at www.k2search.se.