Manager* Safety Operations
- Published: 2022-07-13
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.
Manager* Safety Operations
Your main responsibilities are:
- Ensuring that safety vendor oversight processes are established, including but not limited to:
- PV training,
- Reconciliation activities including solving reconciliation discrepancies,
- Compliance monitoring/tracking with respect to vendor oversight in clinical trials and PV,
- Contract management,
- Day-to-day business, e.g. monitoring of incoming e-mails, answering or coordinating PV-related vendor queries,
- Resource planning for scheduled and ongoing clinical trials as well as other outsourced PV activities.
- Liaising with interfaces, such as Clinical Operations, Quality Assurance, Medical Affairs and Procurement
- Preparation, revision and review of PV-relevant SOPs and other procedural documents
- Perform further PV activities according to regulatory requirements and applicable SOPs
What you have to offer.
- Master's Degree or similar in one of the following areas: Medical (MD or equivalent), Pharmacy or natural/life science.
- At least 2 or 3 years of experience in pharmacovigilance and/or clinical trials within the pharmaceutical industry, biotech or CRO
- Knowledge of GCP, GVP and related global regulations and required processes
- Competency in interaction/cooperation with other departments, partners, vendors and affiliates
- Business fluent in both English (written and spoken) and German (written and spoken)
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 4339 (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!
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