Safety Manager*

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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 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.

Clinical Safety Manager*

In this position, you will contribute - from a safety point of view - to BioNTech's clinical trials according to regulatory requirements and applicable BioNTech SOPs in close cooperation with Clinical Safety Physicians, the Clinical Trial Team and CROs involved.  
 
Your main responsibilities are: 
  • Prepare/Contribute to safety-relevant parts of clinical trial protocols, clinical trial reports, investigator's brochures  
  • Preparation of Safety Management Plans  
  • Processing of SAEs and SUSARs, DLTs, AESls and pregnancy reports originated from clinical trials including query management 
  • Submission of safety reports according to local regulations 
  • Coordinate the preparation of DSURs and ensure their timely submission
  • Perform SAE reconciliation activities 
  • Manage the review and update process of BioNTech´s standard operating procedures 
  • Perform pharmacovigilance training of BioNTech in-house staff, clinical trial teams and, clinical trial site teams as needed
  • Prepare listings, tables or presentations of safety data to support regular safety meetings 
  • Provide input to requests related to clinical safety from Regulatory Authorities/ Ethics Committees or from other functions within BioNTech 

What you have to offer.

  • A qualification in natural sciences (degree/master's/doctorate) in biology, medicine, pharmaceutics or a comparable discipline  
  • Some years of professional experience in clinical safety management 
  • Ability to work highly organized and independently  
  • Experience with different IT systems/ databases, e.g. safety and clinical databases 
  • Very good spoken and written English, and basic German knowledge spoken and written 
  • Sound knowledge of relevant laws, GCP and regulatory requirements concerning clinical safety; knowledge of the guidelines and regulations governing the post-authorisation safety pharmacovigilance (GVP) is desirable 
  • Ideally, experience in MedDRA coding 
     

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz 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 4354 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de