1 pharmacovigilance jobs in Muenchen, Deutschland.

... quality management system including deviation management and CAPA management in collaboration with the quality department - Management and preparation of pharmacovigilance agreements based on corresponding templates incl. maintenance of templates - Management of pharmacovigilance activities of Dr. Falk Pharma affiliates including ...

... culture of compliance and excellence. Ensuring takeover of the following tasks and responsibilities of the Global Safety Product Leads group: - Global pharmacovigilance product responsibility for the medicinal products - Monitoring of the benefit-risk profile - Signal management: signal detection, signal validation, signal ...

Pharmazeut (all genders) im (Pflicht-)Praktikum für 2027 Abteilung: Pharmaceutical Affairs Business Area: R&D, Pharmacovigilance & Regulatory Affairs Stellentyp: Praktikant Vertragsart: Vorübergehend Standort: Hamburg, DE Über uns Wir sind Chiesi – und wir haben eine besondere Mission: Wir wollen das Leben der Menschen ...

... reports and performance updates for internal stakeholders and senior leadership. - Operate in accordance with the ABPI Code of Practice, company policies, pharmacovigilance requirements and all applicable legal and regulatory standards. Required skills and experience (oncology account management & stakeholder engagement) - ...

... practice experience · Understanding of relevant regulations and guidance, including ICH-GCP · Experience within the pharmaceutical industry, CRO environment, pharmacovigilance, project management, clinical development, or another relevant medical function is desirable · Strong communication, analytical, presentation, organizational, ...

... support regulatory interactions, benefit-risk assessments, and evidence-based decision-making in collaboration with clinical development, regulatory affairs, pharmacovigilance, and other key stakeholders. In this role, you will provide medical-scientific oversight of medac’s Managed Access Programs (MAP) and Named Patient Use ...

... internationalen Projekten zur kontinuierlichen Verbesserung unserer Qualitätsprozesse - Du arbeitest eng mit verschiedenen Fachbereichen wie Regulatory Affairs, Pharmacovigilance, Manufacturing, Supply Chain und Quality Assurance zusammen Wen wir suchen - Du hast zum Praktikumsbeginn das zweite Staatsexamen im Studiengang Pharmazie ...

... Indikationen sowie Unterstützung von klinischer Entwicklung und Behördenkontakten. Sicherstellung von Compliance, Inspektionsbereitschaft und wirksamer Pharmacovigilance-Systeme mit der EU-QPPV und externen Dienstleistern. Fachliche und disziplinarische Leitung der Abteilung Regulatory Affairs (7 FTE) inkl. Budgetverantwortung, ...

... expectations. - Ensure all scientific exchange is balanced, accurate, compliant and non-promotional. - Understand and consistently follow medical, regulatory and pharmacovigilance processes. Qualifications - An advanced degree in life sciences or a related healthcare discipline (e.g., PharmD, PhD, MD, MSc or equivalent). - Experience ...