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 Associate*
Your main responsibilities are:
- Operational and organizational support within the Clinical Safety Management team, gaining experience in clinical trials and in clinical trial conduct
- Compilation of safety documents for the trials, filing and tracking of essential documents, preparation of meeting minutes and coordination of meetings
- Support the Clinical Safety Manager during the preparation and review of safety-relevant parts of clinical study protocols, clinical study reports, and investigator's brochures
- Prepare listings, tables or presentations of safety data to support study meetings
- Support the generation of aggregate reports and signal detection activities.
- Perform case processing activities in the global safety database; process and track cases of SAEs, SUSARs, DLTs, AESls, and pregnancy reports in clinical trials, support the case assessment and follow-up activities performed by the Clinical Safety Manager together with the Safety Physician
- Perform TMF filing and/or review of TMF filing of safety-relevant documents
- Support and perform SAE reconciliation
What you have to offer.
- University degree in natural sciences (biology, medicine, pharmaceutics or a comparable discipline); alternatively, medical occupational training (e.g. as a medical documentalist, nurse, medical technical assistant or pharmaceutical technical assistant) with relevant practical experience in clinical safety
- Initial professional pharmacovigilance experience in clinical trials (clinical safety)
- Basic knowledge of relevant laws, GCP and regulatory requirements concerning pharmacovigilance in clinical trials; knowledge of the guidelines and regulations governing post-authorisation pharmacovigilance (GVP) is desirable
- Ability to work independently.
- Good spoken and written English, and basic spoken and written German
- 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 4359 (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