Manager* Safety Compliance & QPPV Office
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Manager* Safety Compliance & QPPV Office
The Manager Safety Compliance & QPPV Office performs specific duties in the Medical Safety & Pharmacovigilance (MSPv) Compliance area as described in the applicable BioNTech standard operating procedures. The Manager Safety Compliance & QPPV Office is assigned to support the set-up and maintenance of Safety Compliance activities.
Your main responsibilities are:
- Manage safety compliance tracking and reporting.
- Prepare, update and/or review safety related procedural documents (e.g. SOPs).
- Support compliance and inspection readiness activities.
- Support training activities.
- Support BioNTech's Regulatory Intelligence activities and oversee PV Intelligence to develop, implement and continuously improve procedural documents and processes.
- Plan and organise multidisciplinary meetings with appropriate stakeholders as required and lead or facilitate the chairing of the meeting.
- Support the record management system to ensure that all safety information is handled and stored in accordance with regulatory requirements.
What you have to offer.
- Advanced degree in life sciences / healthcare (or clinically relevant degree) is required.
- Some years of experience in post-marketing and/or clinical research, biotech or pharmaceutical industry.
- Knowledge of applicable legislation, GCP and GVP regulations in key geographies
- Fluency in written and spoken English
- Knowledge of the concept of data integrity and experience with electronic data management systems to achieve and maintain data integrity throughout its lifecycle.
- Results-oriented working style
- Being accountable for achieving high ethical standards of work and behaviour
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 4368 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
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