- Plan, schedule, conduct and report Pharmacovigilance audits including Service Providers, systems and processes, license partners and affiliates to assure that all are in an acceptable state of compliance
- Document audit conduct, findings, CAPA ensuring supporting documentation, tracking / verification of CAPA commitment implementation are conducted within the electronic quality management systems in a timely manner
- Support all aspects of pharmacovigilance regulatory inspections including preparation, conduct, coordinating responses, evaluating supporting documentation, tracking and verification of CAPA commitment implementation, and effectiveness checks
- Escalate critical findings from audits and inspection to QA and functional department leadership
- Support management of Quality Assurance SOPs and policies to ensure that they are current, adhere to laws, regulations, guidance documents and Daiichi-Sankyo standards
- Support quality documentation and quality system implementation programs
- Liaise and consult with CSPV and others to ensure local and global conformance with regulatory requirements, GvP, internal standards, and to provide proactive integration of quality and process improvement
- Bachelor's Degree in a scientific, health care or related discipline and/or background in Medical health Profession (RN, Medical technologist, etc.) required
- 7 or more years Quality Assurance experience with a world class quality organization in the Pharmaceutical/CRO industry
- 7 or more years First-hand knowledge of GVP Compliance Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products
- 7 or more years Experience of direct dealings with Health Authorities, (e.g., FDA, HPFB, MHRA and other European regulatory agencies)
- 7 or more years International experience is a plus; but at minimum, experiences working with diverse cultures and employees
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Senior Manager PV Audits
Gefunden in: Talent CH C2 - vor 15 Stunden
Daiichi Sankyo Europe Zürich, SchweizPassion for Innovation. Compassion for Patients. · With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the wor ...
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Digital Platforms/Salesforce Partner Sales Senior Manager
Gefunden in: Talent CH C2 - vor 1 Tag
Epam Zürich, SchweizDescription · ABOUT THE ROLE · EPAM is looking for a hybrid Digital Platforms/Salesforce Partner Sales Senior Manager to join our sales team in Zurich. You will be responsible for driving revenue related to our cloud offering by working closely with our internal Digital Consult ...
Medical Technologist - Zurich, Schweiz - Daiichi Sankyo Europe GmbH
Beschreibung
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are seeking qualified candidates to fill the position of