Head Qppv Office and Deputy Qppv

vor 4 Wochen

Ingelheim am Rhein, Deutschland Boehringer Ingelheim Vollzeit

**Head QPPV Office and Deputy QPPV**
**-**
**231570**

At Boehringer Ingelheim, we develop pioneering therapies and health solutions, many of them crucial for patients’ survival. Our team is made up of 52,000 colleagues worldwide. We are a family-owned company and maintain that family feel despite our size.

Patient safety is of utmost importance to Boehringer Ingelheim and we are looking for a

**Head QPPV Office and Deputy EU-QPPV**

reporting into the EU Qualified Person for Pharmacovigilance (QPPV) & Head Regional PS & PV EUCAN /EM - ensuring that Boehringer Ingelheim’s (BI's) PV System is in line with worldwide regulatory requirements in terms of structure and performance.

**Details of the job**

In your role, you will also serve as Functional Quality Representative towards Boehringer Ingelheim’s broader Medicine organization, you will have the opportunity working with cross-functional colleagues from different backgrounds and we’d love you to have the confidence to represent the Patient Safety Pharmacovigilance Department in front of the people you work with.

Together with our process owners, you will lead the development and management of processes and procedures to ensure PV quality and compliance and PV inspection readiness. In heading the QPPV Office, you will identify the team’s priorities and accountabilities to maintain oversight of the PV system across the areas of training and PV system performance, ensuring documentation in the Pharmacovigilance System Master File (PSMF) and efficient audit/ inspection handling.

Regulatory changes in any country of the world could have a global impact, so overseeing PV Intelligence, you need to keep an eye on these changes to decide whether they might necessitate global changes at BI.

You will also oversee and decide on our PV training strategies. This means you will be responsible for designing e-learning and other training and PV awareness material for PV employees at BI worldwide. Working in the leadership team of the EU QPPV & Head Regional PS & PV, you will deputize as Deputy EU-QPPV e.g. in case of absences.

**Your skills, your experience and what makes you who you are**- You have a Master degree in Health Sciences - and if you are a medical doctor, that’s an asset-
- You have a deep understanding of pharmacovigilance and the set-up of a PV system and have acquired experience in this field over several years of working in the pharmaceutical industry and/or regulatory authority.-
- You are experienced in an audit and inspection setting and feel confident to represent the PV system aspects in such settings-
- You have a talent for working in a diverse range of teams, and we love the fact that you are always prepared to discuss your case even when the going gets tough.-
- Our working language is English, so you should be able to speak and write it really well.**What you can look forward to**- You will get to make decisions and move things forward. You will not only be engaged in strategic and theoretical discussions, but also have the opportunity to get more hands-on as and when the situation calls.-
- While we’re happy for you to work from home some of the time, you’ll be required to come to the office the rest of the time - after all, in this job, we prefer face-to-face communication because it makes things so much more personal.-
- We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.**Sounds good?**
Then get in touch. We’re looking forward to it.

**Job**
- Medicine / Regulatory Affairs

**Primary Location**
- Europe-DE-Rhinland-Palatinate-Ingelheim

**Organization**
- DE-BI International GmbH

**Schedule**
- Full-time

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