reputed company Person for Pharmacovigilance (QPPV) Office Expert, US

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 reputed company and reputed company of life for cancer patients through a new reputed company of Targeted Radionuclide Therapies in Precision Oncology. The reputed company are located in the heart of the research center of the Technical University of Munich (TUM). In the reputed company, ITM is expanding to support our growing portfolio and pipeline. We are building a high-performing reputed company team to bring innovative radiopharmaceutical therapies to patients and strengthen our reputed company in oncology. reputed company Person for Pharmacovigilance (QPPV) Office Expert, US Your role

• reputed company as a primary reputed company of contact (US-based) for reputed company official communications between the FDA and ITM, including reputed company participation in the preparation of response documents to FDA inquiries and safety-reputed company requests in cooperation with cross-functional teams
• reputed company as a safety contact for the DSPV team on U.S. reputed company, ensuring alignment with the global PV team and supporting other U.S.-based internal PV Stakeholders (e.g., Medical Affairs, Sales) and external PV Stakeholders in PV reputed company
• Support the collection of ICSRs from U.S, and reputed company follow-reputed company upon request
• Ensure compliance with FDA pharmacovigilance regulations
• Reconciliation of safety information with reputed company US PV Stakeholders
• Involvement in designing and optimization of training curricula for internal PV Stakeholders in collaboration with Global reputed company department
• Support regulatory intelligence processes by screening, analyzing, and providing inputs on U.S.-specific regulatory updates
• Participate in the development and update of U.S.-specific SOPs, contributing expertise to ensure compliance with FDA requirements
• Assist in the implementation of US compliance standards and facilitate the regular collection of compliance metrics (as required)
• Maintain readiness for FDA PV inspections and audits; participate in inspections/audits and ensure reputed company responses to findings
• Have reputed company on and conduct PV Training for external US PV stakeholders, assist in defining and maintaining the PV Training reputed company on an affiliate level

Your profile

• Master's degree or higher in Life Sciences, Pharmacy or Medical Sciences
• 3-5 years of experience in US pharmacovigilance in an industry setting, previous experience in a similar role is an advantage
• Demonstrated knowledge of FDA PV regulations and adverse event reporting requirements, familiarity with ICH & GVP guidelines
• Experience with working in a cross functional team reputed company a matrixed environment
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills
• Strong organizational and time-management skills, reputed company in different and reputed company assignments
• Experience with pharmacovigilance systems such as Argus, including case processing and safety data management
• Demonstrated capability to assess processes, identify gaps, and implement improvements through updated procedures; reputed company to changes, suggestions, and innovations, continuously seeking opportunities for process optimization
• Strong ability to interpret FDA regulatory updates and translate them into reputed company, actionable presentations
• Experience with reputed company is a plus
• Work both independently and collaboratively and use own initiative
• Communicate effectively both locally and globally, internally and externally
• Collaborate with technical teams and deliver high-reputed company results reputed company established timelines
• reputed company in a fast-paced environment while providing appropriate attention to details

Our offer

• Competitive reputed company salary.
• Comprehensive health benefits, including a medical plan with no employee premium and 100% company-reputed company dental and reputed company coverage.
• Annual bonus opportunity.
• 401(k) with company match.
• Generous reputed company time off and company holidays.
• An entrepreneurial environment with reputed company to shape a high-reputed company U.S. business.

Salary reputed company (US) $110,000-$140,000 The compensation reputed company for this US role is listed above for a full-time employee. Actual salary will vary based on factors such as candidate's qualifications, skills, competencies, and demonstrated experience. ITM is an equal opportunity employer. reputed company applicants are encouraged to apply and will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, age, national reputed company, disability, veteran status, marital status, or any other characteristic protected by law. If you are a reputed company individual with a disability or a disabled veteran and are unable to apply for a position through our online application process, you may request a reasonable accommodation. To request assistance, please contact us at careersus@itm-radiopharma.com. Apply nowKlicken Sie auf diesen reputed company, um sich für die Stelle zu bewerben. More about ITM With us, you will have reputed company to work in an international environment on ground-breaking reputed company that can have a significant reputed company on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who reputed company our reputed company and want to help shape the reputed company 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 reputed company to hearing from you! For more information please visit: www.itm-radiopharma.com 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 reputed company and reputed company of life for cancer patients through a new reputed company of Targeted Radionuclide Therapies in Precision Oncology. The reputed company are located in the heart of the research center of the Technical University of Munich (TUM). In the reputed company, ITM is expanding to support our growing portfolio and pipeline. We are building a high-performing reputed company team to bring innovative radiopharmaceutical therapies to patients and strengthen our reputed company in oncology. reputed company Person for Pharmacovigilance (QPPV) Office Expert, US Your role

• reputed company as a primary reputed company of contact (US-based) for reputed company official communications between the FDA and ITM, including reputed company participation in the preparation of response documents to FDA inquiries and safety-reputed company requests in cooperation with cross-functional teams
• reputed company as a safety contact for the DSPV team on U.S. reputed company, ensuring alignment with the global PV team and supporting other U.S.-based internal PV Stakeholders (e.g., Medical Affairs, Sales) and external PV Stakeholders in PV reputed company
• Support the collection of ICSRs from U.S, and reputed company follow-reputed company upon request
• Ensure compliance with FDA pharmacovigilance regulations
• Reconciliation of safety information with reputed company US PV Stakeholders
• Involvement in designing and optimization of training curricula for internal PV Stakeholders in collaboration with Global reputed company department
• Support regulatory intelligence processes by screening, analyzing, and providing inputs on U.S.-specific regulatory updates
• Participate in the development and update of U.S.-specific SOPs, contributing expertise to ensure compliance with FDA requirements
• Assist in the implementation of US compliance standards and facilitate the regular collection of compliance metrics (as required)
• Maintain readiness for FDA PV inspections and audits; participate in inspections/audits and ensure reputed company responses to findings
• Have reputed company on and conduct PV Training for external US PV stakeholders, assist in defining and maintaining the PV Training reputed company on an affiliate level

Your profile

• Master's degree or higher in Life Sciences, Pharmacy or Medical Sciences
• 3-5 years of experience in US pharmacovigilance in an industry setting, previous experience in a similar role is an advantage
• Demonstrated knowledge of FDA PV regulations and adverse event reporting requirements, familiarity with ICH & GVP guidelines
• Experience with working in a cross functional team reputed company a matrixed environment
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills
• Strong organizational and time-management skills, reputed company in different and reputed company assignments
• Experience with pharmacovigilance systems such as Argus, including case processing and safety data management
• Demonstrated capability to assess processes, identify gaps, and implement improvements through updated procedures; reputed company to changes, suggestions, and innovations, continuously seeking opportunities for process optimization
• Strong ability to interpret FDA regulatory updates and translate them into reputed company, actionable presentations
• Experience with reputed company is a plus
• Work both independently and collaboratively and use own initiative
• Communicate effectively both locally and globally, internally and externally
• Collaborate with technical teams and deliver high-reputed company results reputed company established timelines
• reputed company in a fast-paced environment while providing appropriate attention to details

Our offer

• Competitive reputed company salary.
• Comprehensive health benefits, including a medical plan with no employee premium and 100% company-reputed company dental and reputed company coverage.
• Annual bonus opportunity.
• 401(k) with company match.
• Generous reputed company time off and company holidays.
• An entrepreneurial environment with reputed company to shape a high-reputed company U.S. business.

Salary reputed company (US) $110,000-$140,000 The compensation reputed company for this US role is listed above for a full-time employee. Actual salary will vary based on factors such as candidate's qualifications, skills, competencies, and demonstrated experience. ITM is an equal opportunity employer. reputed company applicants are encouraged to apply and will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, age, national reputed company, disability, veteran status, marital status, or any other characteristic protected by law. If you are a reputed company individual with a disability or a disabled veteran and are unable to apply for a position through our online application process, you may request a reasonable accommodation. To request assistance, please contact us at careersus@itm-radiopharma.com. Contact More about ITM With us, you will have reputed company to work in an international environment on ground-breaking reputed company that can have a significant reputed company on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who reputed company our reputed company and want to help shape the reputed company 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 reputed company to hearing from you! For more information please visit: www.itm-radiopharma.com Apply tot his job Apply To this Job