Associate Director* Signal Management

<p></p> <p> </p> <p>Become a member of the BioNTech Family!<br/> <br/> 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.<br/>  <br/> 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.</p> <p><br/>  </p> <p>Associate Director* Signal Management </p> <p> </p> <p>The Associate Director* Signal Management is responsible for leading Signal Management strategy and ensuring high quality as well as compliance in adherence to internal process and external regulations.</p> <p> </p> <p>Your main responsibilities are:</p> <ul> <li>Support the implementation of the process and relevant governance bodies including the implementation into the organisation</li> <li>Oversight on process related activities, ensuring complete documentation and implementation of process outcomes. This includes the management of a signal log to track and follow up on signals throughout their life-cycles</li> <li>Continuous monitoring of process goals to ensure compliance and early identification and mitigation of process related risks</li> <li>Support the implementation, maintenance and training of a validated signal management system</li> <li>Support internal audits or regulatory inspections</li> <li>Act as backup for the Global Process Owner for Signal Management</li> </ul> <p> </p> <p>What you have to offer.</p> <ul> <li>University degree in biomedical sciences, PhD desirable</li> <li>Serveral years of experience in the pharmaceutical industry in pharmacovigilance and/or regulatory affairs and/or quality assurance, preferably including experience with regulatory inspections and follow-up with CAPA plans.</li> <li>Expertise and experience in signal management, risk management and benefit-risk assessment</li> <li>Experience in implementing and training in signal management systems</li> <li>Knowledge and understanding of global PV regulations; experience with regulatory requirements for device management and quality assessment is a plus</li> <li>Fluency in English is mandatory, German a plus</li> <li>Excellent communication and presentation skills</li> <li>Excellent organizational and interpersonal skills in an international environment</li> <li>Excellent ability to prioritize in a changing environment</li> </ul> <h2><br/>  </h2> <p>Benefits for you:</p> <p> </p> <ul> <li>Flexible Working Time</li> <li>Mobile Office</li> <li>Work from EU Countries</li> <li>Company Pension Scheme</li> <li>Childcare</li> <li>Jobticket</li> <li>Company Bike</li> <li>Leave Account</li> <li>Fitness Courses<br/>  </li> </ul> <p>... and much more.<br/>  </p> <p> </p> <p>Have we kindled your pioneering spirit? </p> <p> </p> <p>Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.<br/> <br/> 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).<br/> <br/> Job-ID 5272 (please indicate for inquiries)<br/> <br/> We look forward to your application!<br/> <br/> *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!<br/> <br/> <em>BioNTech - As unique as you</em><br/> <br/> <a href="https://biontech.com">www.biontech.com</a></p>