Global Pharmacovigilance Operations Expert

**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 working model in Garching s soon as possible

**Global Pharmacovigilance Operations Expert (f/m/d)**:
**Your role**:

- **Partner & Vendor Management**:
Manage pharmacovigilance (PV) partnerships and vendors to ensure compliance with SOPs, KPIs, PVAs, and contracts. Prepare and document PV vendor oversight meetings, escalating issues as needed. Support the preparation of PV contractual agreements
- **Process Improvement & Oversight**:
Identify process deviations, contribute to CAPA processes, and develop PV metrics/KPIs for compliance tracking. Supervise case management, propose and implement process improvements, and maintain proper documentation
- **System Maintenance**:
Support the development and maintenance of an international PV system, including SOPs, work instructions, and procedural documents. Manage document change requests (DCRs) and assess the impact of regulatory updates (Pharmacovigilance Intelligence)
- **Audits & Inspections**:
Assist with inspection readiness, audit responses, and inspection follow-ups for PV and vendors.
Cross-Functional Collaboration:
Regularly interact with Clinical Operations, Quality Affairs, and Regulatory Affairs teams globally and locally
- **Training & Leadership Support**:
Deliver training to teams and partners on new processes, support PV leadership, and actively participate in daily PV activities with a hands-on, positive attitude

**Your profile**:

- University degree with a focus on the natural sciences, human medicine or pharmacy
- Professional experience in the pharmaceutical industry, with at least 4 years of experience within drug safety and pharmacovigilance
- Knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally
- Solid experience with safety & quality systems (Argus Safety Database, Veeva Vault QMS) and tracking metrics, compliance monitoring
- Expertise in creation of various PV process accompanied by writing and updating SOPs and work instructions
- Expertise in generating and analyzing data to produce reports and presentations that provide insights into performance
- Independent and structured way of working, attention to detail and accuracy
- Very good knowledge of English, both written and spoken; German language skills are a plus
- Strong communication skills, with the ability to interact effectively with cross-functional teams and external stakeholders

**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**:
Nadine Sürken

+49 89 329 8986 -1709

ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland

**Note for recruitment agencies**

**More about ITM**: