Pharmacovigilance Quality Assurance Manager Stellenangebote


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15 Jobs für Pharmacovigilance Quality Assurance Manager


Stellenangebote Pharmacovigilance Quality Assurance Manager Jobs


Job vor 6 Tagen bei Jobleads gefunden

Clinical Trial Manager-single sponsor

• München, Bayern Clinical Trial Manager-single sponsor Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes [...]
MEHR INFOS ZUM STELLENANGEBOT[...] to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we [. .. ] Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. Serves as an escalation point for communications with investigator site staff and may [. .. ] of other functions roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA) . Supports Inspection Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and [. .. ]

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Job vor 6 Tagen bei Jobleads gefunden

Sponsor Dedicated Global Senior Project Manager (CTL level role) remote-Austria

• Wien Sponsor Dedicated Global Senior Project Manager (CTL level role) remote-Austria Join to apply for the Sponsor Dedicated Global Senior Project Manager (CTL level role) remote-Austria role at Syneos Health 2 [...]
MEHR INFOS ZUM STELLENANGEBOT[...] days ago Be among the first 25 applicants Join to apply for the Sponsor Dedicated Global Senior Project Manager (CTL level role) remote-Austria [. .. ] Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Employs strategic thinking and problemsolving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. Serves as an escalation point for communications with investigator site staff and may be [. .. ] of other functions roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA) . Supports Inspection Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses studyspecific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities [. .. ]

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Job am 25.11.2025 bei Jobleads gefunden

Global PV QA Leader: Strategy, Audits Compliance

• Basel, Basel- Stadt Führungs-/ Leitungspositionen A leading biotech company in Basel is looking for a Global Senior Pharmacovigilance QA Manager. The role involves enhancing compliance within pharmacovigilance, managing audit programs, and maintaining a global PV [...]
MEHR INFOS ZUM STELLENANGEBOT[...] system. The ideal candidate has a masters degree, extensive experience in Drug Safety, and expert knowledge of international regulations. This is a full-time position within the Quality Assurance business area. #J-18808-Ljbffr 70492822 [. .. ]

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Job am 24.11.2025 bei Jobleads gefunden

Global Pharmacovigilance QA Leader Strategy Compliance

• Basel, Basel- Stadt Führungs-/ Leitungspositionen A leading biotech firm is seeking a Global Pharmacovigilance QA Manager in Basel. This role involves driving compliance within the pharmacovigilance domain, overseeing audit programs, and collaborating with internal stakeholders. [...]
MEHR INFOS ZUM STELLENANGEBOT[...] The ideal candidate will have a strong background in Pharmacovigilance and a masters degree in a relevant field, with at least 10 years of experience in Quality Assurance. The position offers a permanent contract with a full-time schedule. #J-18808-Ljbffr 70442893 [. .. ]

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Job am 22.11.2025 bei Jobleads gefunden

Global Pharmacovigilance QA Manager

• Basel, Basel- Stadt Global Senior Pharmacovigilance QA Manager Location: Basel, BS, CH About Idorsia Pharmaceuticals Ltd Headquartered near Basel, Switzerland a European biotech hub Idorsia has a highly experienced team of dedicated professionals, [...]
MEHR INFOS ZUM STELLENANGEBOT[...] covering all disciplines from bench to bedside; QUVIVIQ (daridorexant) , a different kind of insomnia treatment with the potential to revolutionize this mounting public health [. .. ] and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System. Experience in Commercial GDP QA/ Supply Chain QA is an advantage. Act as a primary contact with internal stakeholders (affiliate, corporate functions) , establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues. Take an active role in, and [. .. ] Requirements Strong background in Pharmacovigilance/ Drug Safety and holds a masters degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields) , additional knowledge in Quality Assurance/ Compliance and Auditing. Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations ICH guidelines) of medicinal products for human use In-depth knowledge of pharmaceutical industry practices Experienced in the training of employees on GVP requirements and pharmaceutical industry practices At least 10 years of QA/ industry/ [. .. ]

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Job am 21.11.2025 bei Jobleads gefunden

Global PV QA Leader Audit Compliance

• Basel, Basel- Stadt Führungs-/ Leitungspositionen A leading biotech company in Basel is seeking a Global Senior Pharmacovigilance QA Manager to enhance compliance within their PV system. The ideal candidate will have extensive experience [...]
MEHR INFOS ZUM STELLENANGEBOT[...] in Pharmacovigilance regulations and a background in QA. This position requires a masters degree and strong communication skills, along with a minimum of 10 years in the industry. Work in a collaborative environment to drive impactful quality assurance strategies. #J-18808-Ljbffr 70217310 [. .. ]

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Job am 20.11.2025 bei Jobleads gefunden

Manager (w/m/d) Regulatory Affairs Biocides

• Köln, Nordrhein- Westfalen Manager (w/m/d) Regulatory Affairs Biocides LANXESS Cologne, North Rhine-Westphalia, Germany Join or sign in to find your next job Join to apply for the Manager (w/m/d) Regulatory Affairs Biocides [...]
MEHR INFOS ZUM STELLENANGEBOT[...] role at LANXESS Manager (w/m/d) Regulatory Affairs Biocides LANXESS Cologne, North Rhine-Westphalia, Germany 1 [. .. ] d) Product Information Regulatory Affairs Neuss, North Rhine-Westphalia, Germany 6 hours ago Neuss, North Rhine-Westphalia, Germany 2 weeks ago Senior Manager Regulatory Reporting/ Bankenumfeld (m/w/d) Consultant Quality Assurance and Regulatory Affairs (m/w/d) Bonn, North Rhine-Westphalia, Germany 1 year ago Cologne, North Rhine-Westphalia, Germany 2 weeks ago Cologne, North Rhine-Westphalia, Germany 1 week ago (Senior) Manager Regulatory Reporting/ Risikomanagement (m/w/d) Cologne, North Rhine-Westphalia, Germany 1 week ago Cologne, North Rhine-Westphalia, [. .. ] ago Cologne, North Rhine-Westphalia, Germany 2 weeks ago Regulatory Affairs-Labelling Specialist (w/m/d) Langenfeld, North Rhine-Westphalia, Germany 2 weeks ago Global ICT Business Partner (Regulatory Affairs Pharmacovigilance) Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr 70115425 [. .. ]

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Job am 20.11.2025 bei Jobleads gefunden

Senior Auditor Quality Assurance Manager (m/f/x)

• Baden- Württemberg Jobticket [. .. ] plans based on risk assessments and conduct internal process and vendor audits. Address and escalate serious clinical trial violations, ensuring timely resolution. Contribute to the development and [...]
MEHR INFOS ZUM STELLENANGEBOT[...] maintenance of the Quality Management System (QMS) , focusing on document management, CAPA, deviations, and SOPs. Advise the Clinical Operations team on CAPA management and quality-related issues. Provide independent consultation on GCP-related and quality issues within clinical research. Support the qualification process for clinical development suppliers and lead supplier audits. Train employees on best practices in GCP, GCLP, pharmacovigilance, and clinical trial regulations. Coordinate inspections and audits by regulatory authorities and ensure readiness for external audits. Manage CAPA actions from inspections and support regulatory compliance within R D. Requirements: Masters degree in Natural Sciences, Pharmacy, Medicine, or a related field. At least 8 years of experience as a QA [. .. ] leadership, efficiency, and quality compliance, we encourage you to apply. E-Mail: Tel: 089 26 20 09 25 Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance, Product Management, and Production Industries Medical Equipment Manufacturing and Biotechnology Research #J-18808-Ljbffr 70115649 [. .. ]

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Job am 18.11.2025 bei Jobleads gefunden

Global Senior Pharmacovigilance QA Manager

• Basel, Basel- Stadt [. .. ] a promising inhouse development pipeline; and a specialized drug discovery engine focused on smallmolecule drugs that can change the treatment paradigm for many patients. We are looking [...]
MEHR INFOS ZUM STELLENANGEBOT[...] for a Global Pharmacovigilance QA Manager to join our team Job Responsibilities The Global Pharmacovigilance QA is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/ She independently [. .. ] and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System. Experience in Commercial GDP QA/ Supply Chain QA is an advantage. Act as a primary contact with internal stakeholders (affiliate, corporate functions) , establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues. Take an active role in, and [. .. ] Requirements Strong background in Pharmacovigilance/ Drug Safety and holds a masters degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields) , additional knowledge in Quality Assurance/ Compliance and Auditing. Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations ICH guidelines) of medicinal products for human use. Indepth knowledge of pharmaceutical industry practices. Experienced in the training of employees on GVP requirements and pharmaceutical industry practices. At least 10 years of QA/ industry/ health [. .. ]

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Job am 16.10.2025 bei Jobleads gefunden

Medical Information Manager (m/f/d)

• Wien Work-Life-Balance [. .. ] deep expertise across multiple vaccine modalities, focused on providing either first-, best-, or only-in-class vaccine solutions. Responsibilities We are currently looking for an experienced Medical Information
MEHR INFOS ZUM STELLENANGEBOT[...] class=highlight_text>Manager (m/f/d) to join our Global Medical Affaire team. Represent Valnevas medical/ scientific voice of expertise for assigned products and relevant therapeutic areas, including those of development products. Ensure medico-scientific integrity and regulatory compliance of activities with relevant guidelines and regulations. Serve as a medical consultant between Valneva and its customers regarding medical information, technical complaints, and pharmacovigilance activities, ensuring scientific integrity and regulatory compliance. Represent Valnevas medical and scientific expertise for assigned products and relevant therapeutic areas, including development-stage products. Manage global customer service inquiries: triage and handle medical queries, drug safety topics, and quality complaints in line with applicable SOPs. Provide, document, and track medical/ scientific information related to assigned and development products, ensuring accurate scientific communication. Collaborate with internal departments and external partners (e. g. distribution partners, PV/ MI service providers) involved in medical information, pharmacovigilance, and quality assurance. Support the implementation of AI-driven digitalization of Medical Information Service. Support with the creation of FAQ documents and training materials. Deliver product training sessions for external partners and internal teams. Prepare quarterly medical information reports and statistics, incorporating data from both internal sources and external collaborators. Conduct literature reviews [. .. ]

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Job am 09.10.2025 bei Jobleads gefunden Associate Director, GCP Inspection Lead EMEA Führungs-/ Leitungspositionen [. .. ] for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. At Be One Medicines, we are dedicated [...]
MEHR INFOS ZUM STELLENANGEBOT[...] to advancing the quality of global clinical trials through outstanding regulatory compliance and excellence. As the Inspection Lead reporting to the R D Quality, Sr. Director of Global GCP Inspection Management, youll be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to [. .. ] inspections from Health Authorities ( MHRA, EMA, etc. ) In-depth knowledge of FDA, EU, and ICH GCP guidelines. A minimum of 7 years of experience in GCP-related Quality Assurance within pharmaceutical, biotechnology, or healthcare industries. High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. Fluency in English; additional language skills (e. g. , Spanish, German, French) are a plus. Superior verbal and written communication skills. Ability to thrive in a dynamic, collaborative environment. Significant Contacts You will interact with key stakeholders across various departments, including Quality Assurance, Clinical Operations, Pharmacovigilance, Clinical Business Operation, Regulatory Affairs, and more, playing a pivotal role in our global operations. Travel Requirements This position may require flexible international travel, with a commitment of up to 35 travel, occasionally with short notice. Ready to Make Your Mark? If you are passionate about quality assurance and are [. .. ] Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Be One Medicines by 2x Get notified about new Associate Director Clinical Research jobs in Germany. Clinical Trial Manager Early Phase (f/m/d) Associate Director-Med Tech Clinical Operations Business Development Manager Life Sciences/ Clinical Research (m/w/d) Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr 65374717 [. .. ]

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Job am 20.08.2025 bei Jobleads gefunden Deputy Responsible Person Wholesale/ QM Manager GDP • München, Bayern Deputy Responsible Person Wholesale/ QM Manager GDP Deputy Responsible Person Wholesale/ QM Manager GDP 4 days ago Be among the first 25 applicants Direct message the job poster from [...]
MEHR INFOS ZUM STELLENANGEBOT[...] Kedrion Biopharma Kedrion Biopharma Gmb H, a subsidiary of Kedrion S. p. A. , is a pharmaceutical wholesaler that distributes finished medicinal products derived from human plasma for [. .. ] looking for the next possible date for a Deputy Responsible Person Wholesale/ QM Manager GDP to join our team Purpose of the function In your role as Deputy Responsible Person/ Quality Manager GDP you are the primary quality contact for logistics/ distribution department. You will support the Responsible Person Wholesale according to 52a AMG in the management of quality-relevant activities in the area of storage, transport and distribution of medicinal products (pharmaceutical wholesale) and contribute to the implementation of and [. .. ] risk, deviation and CAPA management Document management Carrying out internal and external audits Creation and management of quality-related documents and contracts Communicating internally with colleagues in the relevant Sales, Pharmacovigilance and Medical Affairs departments and externally with employees of contracted service providers regarding GMP/ GDP-related issues and problems Personal skills and professional experience University/ FH/ Masters degree in natural sciences or pharmacy or equivalent qualification Knowledge of the relevant laws, regulations and guidelines (AMG, AM-Handels V) Experience and knowledge in the areas of GDP and GMP Experience and knowledge of quality assurance and management Experience with logistical processes desirable Strong communication skills, reliability, ability to work in a team Solution-orientated work and a structured way of working A high degree of flexibility and good self-motivation Hands-on mentality and strategic thinking Reliability and high quality awareness Fluent German and English [. .. ]

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Job am 09.07.2025 bei Jobleads gefunden Senior Director, PV Quality Management Lead (m/f/x) Europe • München, Bayern Führungs-/ Leitungspositionen Work-Life-Balance Senior Director, PV Quality Management Lead (m/f/x) Europe Join to apply for the Senior Director, PV Quality Management Lead (m/f/x) Europe role at Daiichi Sankyo Europe Gmb H Senior [...]
MEHR INFOS ZUM STELLENANGEBOT[...] Director, PV Quality Management Lead (m/f/x) Europe Join to apply for the Senior Director, PV Quality Management Lead (m/f/[. .. ] Skills And Professional Experience A minimum of Bachelors degree preferably in healthcare or life sciences required; Medical Doctor, Masters Degree, Pharmacist. Sufficient expertise in local, European and international regulatory and pharmacovigilance requirements. Work experience in pharmacovigilance of at least 12 years, experience, including both investigational and marketed products, and comprising at least 7 years management experience. Reads, writes and speaks English fluently. Develops quality expectations and supervises others within the function; actively develops and implements changes to improve quality within the [. .. ] us? What we offer Work-Life-Balance Growth and Development Health and Wellbeing Support Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Daiichi Sankyo Europe Gmb H by 2x Get notified about new Director Quality Management jobs in Munich, Bavaria, Germany. Supply Chain Excellence Manager DACH (m/w/d) Director Quality/ Qualified Person-Europe Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr 54838706 [. .. ]

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Job am 09.07.2025 bei Jobleads gefunden Global Pharmacovigilance QA Manager [. .. ] in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. We are looking for a [...]
MEHR INFOS ZUM STELLENANGEBOT[...] Global Pharmacovigilance QA Manager to join our team Job Responsibilities The Global Pharmacovigilance QA is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/ She independently [. .. ] and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System. Experience in Commercial GDP QA/ Supply Chain QA is an advantage. Act as a primary contact with internal stakeholders (affiliate, corporate functions) , establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues. Take an active role in, and [. .. ] Requirements Strong background in Pharmacovigilance/ Drug Safety and holds a masters degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields) , additional knowledge in Quality Assurance/ Compliance and Auditing. Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations ICH guidelines) of medicinal products for human use. In-depth knowledge of pharmaceutical industry practices. Experienced in the training of employees on GVP requirements and pharmaceutical industry practices. At least 10 years of QA/ industry/ [. .. ]

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Job am 06.07.2025 bei Jobleads gefunden Engagement Manager-R D (Remote) • Berlin [. .. ] our leading R D consulting practice is a strategic priority for Veeva, with high visibility within the company and to leaders of the wider Life Sciences industry. [...]
MEHR INFOS ZUM STELLENANGEBOT[...] As an Engagement Manager, you will manage complex and novel consulting projects for Veeva customers in the research and development (R D) space managing teams and planning, organizing, and tracking all aspects of delivery. You will support building our brand in the market, developing our customer network, and identifying and acquiring new projects to support our customers to deliver on their complex business challenges. As part of the team, you will focus on one or more critical areas such as Clinical Development, Regulatory Affairs, Pharmacovigilance/ Drug Safety, and Quality Management. What Youll Do Lead multiple project engagement teams empowering the team to plan and manage all aspects of delivery, from scope to quality assurance Be responsible for the end-to-end design, build, and delivery of deliverables that meet overall project goals and objectives Proactively lead business development opportunities identify and generate new project opportunities, clarify customers challenges and needs, be able to develop a compelling, differentiated proposal to solve these issues and win [. .. ]

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Die meisten Stellenanzeigen für Pharmacovigilance Quality Assurance Manager Jobs werden derzeit in Bayern (3 Jobs), Baden-Württemberg (1 Jobs) und Nordrhein-Westfalen (1 Jobs) angeboten.


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