Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können
-
Director, Eu Qppv
vor 3 Monaten
Munich, Deutschland Apellis Pharmaceuticals Vollzeit**Position: Director, Qualified Person Responsible for Pharmacovigilance in the EU (EU QPPV)** **Reports to: Sr. Director, PV International** **Location: Munich, Germany** **Position Summary**: The EU QPPV is responsible for the establishment and maintenance of the pharmacovigilance (PV) system and ensuring the system is compliant with EU regulations and...
-
Stufenplanbeauftragter (M/w/d)
vor 3 Monaten
Munich, Deutschland PARI Firmengruppe VollzeitJetzt haben Sie es in der Hand! Erleichtern Sie Menschen, die an Atemwegserkrankungen leiden, und denen, die sich um sie sorgen und kümmern, das Leben. Wir von PARI entwickeln als forschendes Medizintechnik - und Pharmaunternehmen modernste Inhalationstechnologien für freies Atmen. Ihre Ideen bringen frischen Wind in den Markt. Fassen Sie am Standort ...
-
Head of Drug Safety Germany
vor 3 Monaten
Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit[6275] Unser Kunde ist einer der wichtigsten Impfstoffhersteller der Welt und entwickelt in vielen weiteren Bereichen wegweisende und wichtige Medikamente, die jeden Tag Millionen von Patient:innen weltweit ein besseres Leben verschaffen. Der Standort Deutschland ist traditionell mit hoher Priorität für unseren Kunden versehen und die Sicherheit der...
-
Responsible Person Germany
vor 3 Monaten
Munich, Deutschland Apellis Pharmaceuticals VollzeitPosition**:Responsible (RP) Person Germany** Reporting into: Sr. Director International Quality & Responsible Person (RP) Switzerland with Dotted Line to GM Germany GmbH **Position Summary**: Acting as the Responsible Person (RP) of Apellis, Germany GmbH as required by - 52a AMG. Legal Basis: - 52a AMG, -- 1a, 4a, 6, 7a, 7b AMHandelsV, - 2.2, 2.3 EU GDP,...
-
Bereichsleiter Phytopharmaka
vor 3 Monaten
Munich, Deutschland Andris Consulting GmbH VollzeitSie haben Erfahrung in der Entwicklung, Herstellung und Zulassung von pflanzlichen Arzneimitteln, Medizinprodukten o. Lebensmitteln? Sie wollen sich als erfahrene Führungskraft weiterentwickeln und legen Wert auf eine wertschätzende Unternehmenskultur? Im Zuge der Nachfolgeplanung für den Renteneintritt eines Geschäftsführers bietet ein bekanntes OTC...
-
Gesamtleitung Herstellung, Qm, Entwicklung
vor 3 Monaten
Munich, Deutschland Andris Consulting GmbH VollzeitSie haben Erfahrung in der Entwicklung, Herstellung und Zulassung von pflanzlichen Arzneimitteln, Medizinprodukten o. Lebensmitteln? Sie wollen sich als erfahrene Führungskraft weiterentwickeln? Im Zuge der Nachfolgeplanung für den Renteneintritt eines Geschäftsführers bietet ein bekanntes OTC Pharmaunternehmen im Großraum München eine spannende...
-
Deputy Flagshipstore Manager
vor 3 Wochen
Munich, Deutschland Vodafone GmbH VollzeitDeputy Flagshipstore Manager (m/w/d) für die Vodafone Filiale in München (Marienplatz 25) Jetzt bewerbenDienstsitz München Vertragsart Unbefristet Arbeitszeit Vollzeit oder vollzeitnahe Teilzeit Beginn sofort Was Dich erwartet:Du arbeitest daran Kund:innen zu begeistern, beraten sowie zu binden und agierst als Ansprechpartner:in für kleine...
-
Nachfolgeplanung: Bereichsleitung Herstellung, Qm
vor 3 Monaten
Munich, Deutschland Andris Consulting GmbH VollzeitSie sind eine führungserfahrene QP (-- 14 15 AMG) in der Phyto-Pharmabranche? Sie haben Erfahrung in der Entwicklung, Herstellung und Zulassung von pflanzlichen Arzneimitteln, Medizinprodukten o. Lebensmitteln? Sie wollen sich beruflich und persönlich weiterentwickeln und verbringen Ihre Freizeit gerne in den Alpen? **Dann packen Sie Ihren Rucksack und...
-
Deputy Assistant Store Manager
vor 2 Monaten
Munich, Deutschland Zimmermann VollzeitZIMMERMANN is one of Australia's leading and most respected fashion designer brands. Zimmermann's ready-to-wear and swim and resort collections are sold through Zimmermann boutiques and high-end retailers both in Australia and internationally. We maintain stand-alone retail stores throughout Australia, EU, UK the USA and a successful online...
-
Deputy Assistant Store Manager
vor 2 Wochen
Munich, Deutschland Zimmermann VollzeitZIMMERMANN is one of Australia's leading and most respected fashion designer brands. Zimmermann's ready-to-wear and swim and resort collections are sold through Zimmermann boutiques and high-end retailers both in Australia and internationally. We maintain stand-alone retail stores throughout Australia, EU, UK the USA and a successful online...
-
Leiter Herstellung
vor 3 Monaten
Munich, Deutschland Andris Consulting GmbH VollzeitSie sind eine herausragende Führungspersönlichkeit mit Erfahrung in der Entwicklung, Herstellung und Zulassung von pflanzlichen Arzneimitteln, Medizinprodukten und Lebensmitteln? Sie wollen strategische Verantwortung übernehmen und sich in einer übergeordneten Führungsrolle weiterentwickeln? **Dann nutzen Sie diese Chance**: Als Prokurist\*in mit...
-
Regulatory Compliance Expert
vor 3 Monaten
Munich, Deutschland Baumlink VollzeitFor a leading financial services institution based near to Frankfurt..._ Your role - Be the go-to person for all internal and external questions about regulatory matters. - Keep an eye on regulatory changes and make sure they're implemented properly. - Maintain the legal inventory for the company - Communicate and coordinate with regulators, namely with...
-
Deputy Director of Semiconductor Applications
vor 3 Monaten
Munich, Deutschland CONCAPE VollzeitCONCAPE ist ein spezialisierter Personalvermittler (Direktvermittlung) für die Region Ostschweiz und Liechtenstein. In dieser Vakanz unterstützen wir ein stark technisch verankertes Unternehmen, welches im Bereich High-Tech führend weltweit führend ist. **Rahmendaten zum Job**: **Arbeitsort**: Ostschweiz, Bodensee, Schweiz **Home-Office**: Bei wohnhaft...
-
Environment, Social and Governance
vor 2 Wochen
Munich, Deutschland Qualcomm VollzeitCompany: Qualcomm Germany GmbH Job Area: Legal Group, Legal Group > Legal Counsel General Summary: Qualcomm Incorporated is seeking an experienced Environmental, Social and Governance (“ESG”) attorney with 5+ years of related experience (e.g., ESG, environmental regulations, emissions regulations, etc.). This attorney will be...
-
Associate Director, Quality Assurance Specialist
Vor 3 Tagen
Munich, Bayern, Deutschland Organon VollzeitAbout the RoleOrganon is seeking a highly skilled Associate Director, Quality Assurance to join our team in ensuring compliance with external and internal requirements pertaining to wholesaling and distribution activities.This role will serve as the Quality Responsible Person (QRP) for the Wholesale Distribution Authorization (WDA) for our company in Germany...
-
Global Medical Services
vor 3 Monaten
Munich, Deutschland GE Healthcare Vollzeit**Job Description Summary**: GE HealthCare’s Global Medical Services (GMS) organization includes the Global Pharmacovigilance and Medical Affairs groups in the Pharmaceutical Diagnostics (PDx) business. As a GMS Compliance and regional PV specialist, you will be part of the GMS Organization reporting into the Compliance and Training Function. You will...
-
General Counsel
vor 3 Monaten
Munich, Deutschland Scalable GmbH VollzeitCompany Description Scalable Capital is a leading digital investment platform in Europe. Since our foundation in 2014, we pursue the mission to empower everyone to become an investor. With the Scalable Broker, Scalable Wealth, Scalable Crypto and our solutions for B2B partners we offer easy and cost efficient investing for everyone. Today, Scalable Capital...
-
Assistant Chief Engineer
vor 3 Monaten
Munich, Deutschland Marriott International Vollzeit***work permit for EU/Germany and German language skills are mandatory*** The Munich Marriott City West sets new benchmarks and standards in meetings & events. Inspired by the Bavarian lifestyle and with 398 guest rooms and suites and nearly 5000 sqm of public space, including a state-of-the-art conference center, customized and first-class event needs...
-
Associate Director, Quality Assurance
vor 1 Monat
Munich, Deutschland Organon VollzeitJob DescriptionOrganon is looking for an Associate Director, Quality Assurance, who will be a key player in the local office in ensuring compliance with external and internal requirements pertaining to wholesaling and distribution activities.You will hold the role as Quality Responsible Person (QRP) for the Wholesale Distribution Authorization (WDA) for our...
Deputy Eu Qppv
vor 2 Monaten
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Join us as a Founder of our ‘new’ Sandoz
**Your job purpose**:
The Deputy EU-QPPV for Sandoz fulfill all the requirements of this role as indicated in the Guidelines on Good Pharmacovigilance Practice (GVP), either directly or through supervision.
The deputy EU-QPPV is responsible for supporting the EU-QPPV in:
- Establishing and maintaining the global Sandoz Pharmacovigilance (PV) system for medicinal products in compliance with GVP requirements.
- Having oversight of the safety profiles and any emerging safety con-cerns in relation to the medicinal products and combined medical devices for which Sandoz holds marketing authorizations.
- Having oversight of the quality management system for the PV system, in collaboration with the QA function.
- Acting as a single contact point in Sandoz for the EU/EEA Competent Authorities and for the UK national competent authority on a 24-hour basis.
- Acts as Quality System Owner for the Sandoz Vigilance System.
**Your key responsibilities**:
- Act as deputy EU-QPPV for Sandoz to fulfill role requirements as indicated in the Guidelines on Good Pharmacovigilance (PV) Practice (GVP), directly or through supervision:
- Single contact point in Sandoz for EU/EEA Competent Authorities on a 24-hour basis and manage/cascade safety related requests for systems or drug safety related in-formation to ensure any requests are answered fully and promptly.
- Assess impact of new PV-related legislation with focus on EU/EEA and provide support to other functions on strategic impact of any changes.
- Oversight of safety profiles and any emerging safety concerns in relation to medicinal products for which Sandoz holds marketing authorizations.
- Collaborate as required in audits / inspections and response processes.
- Oversight of the quality management system for the PV system, in collaboration with the QA function.
- To establish and maintain a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the Marketing Authorization Holders (MAHs), and its medical representatives, is collected and collated in order to be accessible at least at one point within the European Un-ion/European Economic Area (EU/EEA) and the UK.
- To ensure a complete oversight of the structure and performance of the Sandoz global PV system, in order to promote, maintain and improve compliance covering the following aspects:
- Quality control and quality assurance/audit plan and audit reports;
- Global working procedures and databases operations;
- Expediting ICSR reporting and aggregate reports (PSURs, DSURs and RMPs) in relation to quality, focusing on accuracy, completeness and timeliness;
- Training of personnel in relation to PV and Risk Management
- Licensing agreements;
- Post-authorisation safety studies, with appropriate input (including at CMO & PS Leadership Meetings) as required.
- To ensure timely and quality preparation (together with PV, Regulatory Affairs (RA) and Medical Safety) the appropriate medical input to PV reports including:
- Individual Case Safety Reports (ICSRs)
- Periodic Safety Update Reports (PSURs)
- Company-sponsored post-authorization safety studies (PASS)
- Risk Management Plans (RMPs) for Competent Authorities of the Member States where the medicinal product is au-thorized, and for the UK National Competent Authority.
- To ensure (through supervision), that the post-authorisation commitments are ful-filled completely together with Regulatory Affairs, Medical Safety and Safety Sciences, with appropriate medical input.
- To ensure that any PV request from the EU/EEA Competent Authorities, or from UK National Competent Authority, for the provision of additional information necessary for the evaluation of the benefits and the risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned.
- To conduct continuous overall PV evaluation during the post-authorization period. This includes oversight of PV operations in Europe/EEA and non-EU/EEA countries with QPPV requirements together with PV, Safety Operations & Compliance, Medical Safety & Risk Management, Regional and the Country Patient Safety Head network in order to ensure complete oversight of the structure and performance in country systems and across Patient Safety.
- To collaborate as required in audits/inspections and response processes in the EU/EEA region and non-EU/EEA countries with local QPPV requirements together with Sandoz Global Development and UK Development QA and Regional Pharmacovigilance/Quality Head, and UK Head of Safety/ UK Head of Quality.
- To assess the impact of new pharmacovigilance related legislation with focus on EU/EEA and provide strategic support to Sando
