Global Pharmacovigilance Compliance Expert

vor 2 Wochen

Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

Your Role:

- Own PV deviation investigations, perform root cause analysis, identify corresponding corrective and preventative actions (CAPAs)
- Monitor Key Process Indicators (KPIs) for reporting PV compliance metrics
- Support PV 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

What we are looking for:

- 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, management of KPIs, 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
- Detail and solution-oriented, and comfortable working in dynamic work environment

What we offer:

- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits

At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.

Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.

Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?

Then send us your detailed CV including earliest start date and salary expectations. Applications are accepted only in English language.

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