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 remote-based or hybrid working model in Garching as soon as possible
Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragte (f/m/d)
Your role
- Fulfil the role of the GPO during the absence of the appointed GPO, according to the relevant legislation and guidelines
- Set up and manage a pharmacovigilance system (§ 63a of AMG)
- Collect and evaluate reports of drug risks and coordinate the necessary measures and responsibility for fulfilling notification obligations insofar as they relate to drug risks (§ 63a of AMG and § 19 of AMWHV)
- Inform the qualified person of the necessary measures (§ 19 of AMWHV & § 14 of the Medicines Act)
- Inform the competent authority immediately of any defect that could lead to a recall or an unusual restriction on distribution and shall also state the countries to which the medicinal product was shipped or exported
- Inform the authority immediately of any suspicion of counterfeit medicinal products or active ingredients; in the case of medicinal products intended for human use, the marketing authorisation holder shall also be informed
Your profile
- Completed degree of a Medical Doctor, Pharmacist or equivalent with extensive work experience in a similar role in pharmacovigilance
- Experience working in a cross functional team within a matrix environment
- Advanced knowledge of regulations governing Pharmacovigilance in the pharmaceutical industry and R&D processes in Europe and globally
- Excellent analytical, problem-solving, strategic planning, and interpersonal skills
- Open to changes, suggestions and innovations, drive for continuous improvement
- Fluent in English and German
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
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