Global Pharmacovigilance Officer

vor 2 Wochen

Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

**Your Role**:

- Lead and coordinate administrative activities for the Global Drug Safety & Pharmacovigilance team. This will require close interaction with all team members as well as with the Oncologics administrative team
- Pharmacovigilance Mailbox management: act as key user for assigned mailboxes; manage and oversee routine tasks in the Pharmacovigilance team from task allocation to task closure
- Reconciliation management: support roll-out of reconciliation and follow-up of responses from Partners (internal and external); facilitate resolution of inconsistencies
- Contract management: support maintenance of records and stakeholders’ databases
- Coordination and handling of internal and external expert meetings, internal boards, and clinical trial safety board meetings
- Organization and coordination of team meetings
- Global Drug Safety & Pharmacovigilance budget handling: Invoice management and hold budget overview. Preparing regular overviews of budget / keeping track of department budget sheet
- Administrative management of global and local Pharmacovigilance Vendors
- Quality and compliance: support preparation and review process of the Pharmacovigilance system Key Performance Indicators
- SOP management: maintain overview of the Pharmacovigilance QMS, support organization of system improvement activities and deliverables, manage training curricula and learner roles for the team
- Coordinate and optimize process management within the Drug Safety & Pharmacovigilanc team, including document retention and archive
- Lead the setup and maintenance of the ITM Global Drug Safety and Pharmacovigilance intranet
- Be curious to engage in cross-functional projects in various GxP areas

**What we are looking for**:

- Degree level education
- Good administrative skills to enable working in a large corporate matrix environment
- Previous experience in the pharmaceutical industry, including a PV department is a plus
- Experience managing budgets including annual budget planning and reporting is a plus
- High proficiency with Microsoft Office including PowerPoint presentations, Excel Spreadsheets
- Project management experience would be an advantage
- Demonstrated leadership skills, with a proactive, strategic mindset
- Fluent written and spoken English

**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. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.

  • Global Pharmacovigilance Operations Expert

    vor 2 Wochen

    Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

    **Your Role**: - Responsible for maintaining an overview of existing ITM PV procedural documents and associated document change requests (DCRs) - Interact with and be the PV delegate for the local and global SOP committees - Coordinate and ensure PV input into relevant non-PV owned procedural documents - Track, prioritize and coordinate/ execute the...

  • Pharmacovigilance Specialist

    vor 1 Woche

    Munich, Bayern, Deutschland Progressive Vollzeit

    Have you already gained initial experience in Drug Safety or Pharmacovigilance, bring along knowledge in PV-reports from Rx-Logix and are now ready to take the next step with a leading biotechnology company? If so, you could be the ideal candidate for the following opportunity I am currently managing:Pharmacovigilance Associate (gn) - HomebasedYour...

  • Global Clinical Development Lead Infections

    vor 2 Wochen

    Munich, Deutschland Proclinical Vollzeit

    Proclinical is seeking to hire a Global Clinical Development Lead Infections located in Munich, Germany for a biotech establishment. **Responsibilities**: - Lead the global development team (in liaison with the responsible program manager) for assigned programs, communicating the strategy, and providing clinical and scientific guidance to cross-functional...

  • Global Compensation

    Vor 3 Tagen

    Munich, Deutschland Global Savings Group Vollzeit

    Global Savings Group is Europe's largest and most trusted shopping rewards platform, empowering millions of people to make better purchase decisions. GSG values a culture of belonging, where you can join a talented team of 600+ people from more than 50 countries in 12 office locations. With us, you will reach millions of customers worldwide, connecting them...

  • Global Compensation

    Vor 3 Tagen

    Munich, Deutschland Global Savings Group Vollzeit

    Global Savings Group is Europe's largest and most trusted shopping rewards platform, empowering millions of people to make better purchase decisions. GSG values a culture of belonging, where you can join a talented team of 600+ people from more than 50 countries in 12 office locations. With us, you will reach millions of customers worldwide, connecting them...

  • Global Compensation

    Vor 3 Tagen

    Munich, Deutschland Global Savings Group Vollzeit

    Global Savings Group is Europe's largest and most trusted shopping rewards platform, empowering millions of people to make better purchase decisions. GSG values a culture of belonging, where you can join a talented team of 600+ people from more than 50 countries in 12 office locations. With us, you will reach millions of customers worldwide, connecting them...

  • München & Home Office: Teilzeit

    Vor 3 Tagen

    Munich, Deutschland Triga Consulting GmbH & Co KG Vollzeit

    Für unseren Kunden ein international erfolgreiches Unternehmen mit Standort in München - suchen wir derzeit Sie in Teilzeit mit 2 Tagen vor Ort in München als Pharmacovigilance Mitarbeiter (m/w/d) Aufgaben - Bearbeitung und Koordination des Pharmakovigilanz-Systems - Fallbearbeitung und Nachverfolgung - Erstellung von SOPs - Mitwirkung in den Bereichen...

  • Global Gvp Auditor

    Vor 7 Tagen

    Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

    **Your Role**: - Implementation, management and oversight of the ITM GVP audit schedule - Lead the development and implementation of the PV audit strategy in alignment with the QPPV and R&D organization - Responsibility for the execution of the PV audit schedule - Ensure the conduct of GVP external vendor, commercial partner, and internal process/system...

  • Working Student

    vor 2 Wochen

    Munich, Deutschland Allianz Global Corporate & Specialty Vollzeit

    **Applicant Information** For further information please contact: Ms. Ivanna Zakharevych Whether it’s airplanes, satellites, the world’s biggest ships and tallest building, cyber-attacks or climate change impacts, Allianz Global Corporate and Specialty (AGCS) have got the major risks fully covered when it comes to protecting businesses. **Job Purpose/...

  • Global Director of Science and Regulatory

    vor 1 Woche

    Munich, Deutschland Klick Health Vollzeit

    For the past 25 years Klick Health has helped life science clients bring their groundbreaking ideas to market. We’ve also spent that time creating an ecosystem for talented and empathetic individuals to chase their passions while creating long-lasting friendships in the process. What does that mean for you? Well, we grow a lot—like every year for 25...