The Grünenthal Group is an independent, family-owned international research based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain, its objective is to become the most patient-centric company to be a leader in therapy innovation. Grünenthal is one of the last five research-oriented pharmaceutical corporations with headquarters based in Germany which sustainably invests in research and development. These investments amounted to about 25 % of revenues in 2011. Grünenthal’s research and development strategy concentrates on select fields of therapy and state-of-the-art technologies. We focus on the intensive search for new ways to treat pain better, more effectively and with fewer side-effects than before. Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries and approx. 4,200 employees are working for the Grünenthal Group worldwide.
In order to strengthen our Grünenthal team, we are currently looking for a
Drug Safety System Manager (m/f)
- Identify and support implementation of pharmacovigilance (PV) regulatory requirements (guidelines, regulations, directives, reporting obligations, etc.).
- Interact with competent authorities, external organizations, internal departments and Grünenthal subsidiaries worldwide in collaboration with the Qualified Person for Pharmacovigilance (QPPV).
- Support the QPPV in having oversight over the global PV system. This includes the monitoring of global quality metrics concerning drug safety and regular reports from subsidiaries.
- Preparation, negotiation, oversight and maintenance of global drug safety agreements.
- Support the globalization of standard operating procedures (SOPs) and implementation in the respective Grünenthal subsidiaries in collaboration with Quality Assurance (QA).
- Organize and support the global drug safety training.
- Prepare and lead the documentation for audits and inspections together with the Corporate Quality Assurance Department.
- Manage contributions from external experts and specialists from other Grünenthal departments in order to achieve the corporate goals in the drug safety environment, in collaboration with the QPPV.
- An advanced scientific or medical university degree (PhD preferred)
- Several years of experience in Drug Safety on an international level
- Experience in interacting with regulatory authorities
- Very good knowledge of English (both orally and in writing); knowledge of German and/or Spanish would be a plus
You convince us by your strong goal- and performance-orientated as well as independent and focused method of operation. Furthermore you have a confident association with colleagues and external partners (national and international). A high degree of engagement and assertiveness as well as very good communication skills complete your profile.
We offer an exciting and challenging role in an international environment where you can make a difference and where you can learn and grow.
If you feel that this is just the right job for you, please submit your application here online! Please submit your CV, Cover Letter, certificates and references as well as information about your earliest availability and your salary expectation.
Grünenthal GmbH & Co. KG
Global Human Resources, Jörg Meurer, Job-ID: 5576, 52099 Aachen