About ITM
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
We would like to fill the following permanent vacancy in a hybrid working modell in Garching as soon as possible
Global Pharmacovigilance Compliance Expert (f/m/d)
Your role
- Own pharmacovigilance deviation investigations, perform root cause analysis, identify corresponding corrective and preventative actions (CAPAs)
- Maintain and monitor pharmacovigilance system relevant quality indicators to ensure compliance with applicable pharmacovigilance relevant processes
- Support pharmacovigilance Audits/Inspections by facilitating requests and/or participating in applicable roles
- Work closely with all stakeholders in the pharmacovigilance department to understand existing processes and procedures, and identify gaps and opportunities for improvement in both effectiveness and efficiency
- Develop a professional relationship with existing pharmacovigilance vendors and establish a management and oversight program to assess both the quality and the compliance of deliverables
- Participate in both departmental and cross-functional meetings and initiatives to increase the awareness, education, training, and leadership for pharmacovigilance compliance
- Identify and support training programs for members of the pharmacovigilance department
Your profile
- Successfully completed Bachelor’s degree in science; Master’s degree preferred
- Robust and sound knowledge of Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV), and International Conference of Harmonization (ICH) regulations regarding drug development
- Multiple years of work experience in compliance and quality management systems including deviation/CAPA management, late case investigations, quality indicators management, management of PV documents and trainings, PV audits and regulatory inspections
- Ideally experience in oncology development, post-marketing programs and development and implementation of compliance processes in a pharmacovigilance setting
- Solid written and oral communication skills in English and German
- Detail and solution-oriented, and comfortable working in dynamic work environment
Our offer
- Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
- An open working atmosphere in an international corporate culture with short communication channels
- Comprehensive onboarding programme
- Flexible working hours with home office options
- Attractive special payments
- Just a good salary? Not with us! We also offer you Employee participation programme
- Job bike or subsidised job ticket
- Above-average contribution to the company pension scheme
- Individually tailored further training programme (including German and English courses)
- Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)
Do you have these qualifications, are you willing to develop yourself further and are you looking forward to becoming a key part of our future? Great! We should get to know each other!
When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.
Contact
Deborah Angelè
+49 89 329 8986 1705
career@itm-radiopharma.com
ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland
Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!
More about ITM
With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit: www.itm-radiopharma.com
