Clinical Safety Manager*

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.

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

•           Conduct signal management activities in close cooperation with the Safety Physicians

•           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 or lead 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, medical technology or a comparable discipline 

•           Some years of professional experience in clinical safety management

•           Experience with in-vitro diagnostics and/ or combination products

•           Good understanding of regulatory requirements and reporting obligations applicable to in-vitro diagnositics.

•           Ability to work highly organized and independently 

•           Strong interpersonal communication and organizational skills

•           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 post-authorisation pharmacovigilance (GVP) is desirable

•           Ideally, experience in MedDRA coding

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 5531 (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

www.biontech.com