Become a member of the BioNTech Family!
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*
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
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
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