Drug Safety Manager

vor 1 Woche

Wien, Wien, Österreich AOP Orphan Pharmaceuticals GmbH Vollzeit
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.

To enhance our team in Vienna we are looking for a:

Drug Safety Manager (f/m/d):

  • 1190 Vienna
  • Fulltime employee
**- As member of the Drug Safety team you collect safety information from various sources, SAE reconciliation, quality control of safety Data entry, and compliance of individual case safety reports (ICSR) to regulatory authorities and business partners._

***
What Your Day To Day Will Look Like
**- Implement and coordinate all pharmacovigilance processes in accordance with the regulatory requirements and applicable SOPs

  • Create and maintain pharmacovigilancerelevant documents on time
  • Compile and control Periodic Safety Update Reports (PSUR)
  • Manage creation and update of Risk Management Plans (RMPs) as well as implementation of additional Risk Minimization Measures (aRMMs)
  • Carry out signal management tasks and lead Safety Review Meetings (SRMs)
  • Compile and process incoming safety case reports (ICSR) in cooperation with medical experts
  • Ensure the compliance of our partners and act as their contact person
  • Support the planning and implementation of PV audits

Your

Qualifications and Experience
**- Completed scientific studies/ technical college degree

  • Several years of experience in the field of pharmacovigilance / drug safety
  • Indepth knowledge of the relevant laws and regulatory requirements for pharmacovigilance
  • Stressresistant personality with accuracy in documentation
  • Strong communication skills in English and German
  • IT skills (Office 365, Adobe Acrobat)

Our Offer
**- Open corporate culture with the opportunity to bring in your own ideas

  • Great opportunities for personal and professional development
  • Attractive work environment with excellent career opportunities and flat hierarchies
  • Competitive salary package plus bonus and various benefits
  • Structured onboarding and a buddy system
  • Gross monthly salary provided for this function is a minimum of EUR based on fulltime employment. Any potential overpayment depends on professional experience and qualifications.
  • If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative"_
- _

Introduction:

Main Benefits:

  • Bonus
  • Homeoffice
  • Employee mobile phone
  • Flexible working hours
  • Laptop
  • Initial and continuing education
  • Canteen
  • Good transport connection
  • Employee events
  • Company doctor
  • Parking spot
  • Healthmeasures
    Your Contact:
***
Kathrin Breuer
******

***- Further information on our website:_

  • Global Drug Safety Physician,

    vor 1 Woche

    Wien, Wien, Österreich BAXTER Vollzeit

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...

  • Drug Safety Scientist

    vor 1 Woche

    Wien, Wien, Österreich BAXTER Vollzeit

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...

  • Drug Safety Scientist

    vor 1 Woche

    Wien, Wien, Österreich BAXTER Vollzeit

    **This is where you save and sustain lives**At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in...

  • Local Safety Officer

    vor 1 Woche

    Wien, Wien, Österreich Sitero LLC Vollzeit

    Local Safety Officer (Remote - Pharmacovigilance)Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase...

  • Construction Area Safety Manager

    vor 1 Woche

    Wien, Wien, Österreich Microsoft Vollzeit

    Microsoft Cloud Operations + Innovation (CO+I) is the engine that powers Microsoft's cloud services. The team is responsible for designing, building and operating our unified global datacenters; managing the demand planning and capacity utilization of our unified infrastructure; and all of the operations needed to run the physical infrastructure (including...

  • Construction Area Safety Manager

    vor 1 Monat

    Wien, Wien, Österreich Microsoft Games Vollzeit

    Microsoft Cloud Operations + Innovation ( CO+I) is the engine that powers Microsoft's cloud services. The team is responsible for designing, building and operating our unified global datacenters; managing the demand planning and capacity utilization of our unified infrastructure; and all of the operations needed to run the physical infrastructure (including...

  • Project Safety Manager

    vor 1 Woche

    Wien, Wien, Österreich Bosch Group Vollzeit

    UnternehmensbeschreibungBei Bosch gestalten wir Zukunft mit hochwertigen Technologien und Dienstleistungen, die Begeisterung wecken und das Leben der Menschen verbessern. Unser Versprechen an unsere Mitarbeitenden steht dabei felsenfest: Wir wachsen gemeinsam, haben Freude an unserer Arbeit und inspirieren uns gegenseitig. **Willkommen bei Bosch.**Die Bosch...

  • Project Safety Manager

    vor 1 Woche

    Wien, Wien, Österreich Bosch Group Vollzeit

    UnternehmensbeschreibungBei Bosch gestalten wir Zukunft mit hochwertigen Technologien und Dienstleistungen, die Begeisterung wecken und das Leben der Menschen verbessern. Unser Versprechen an unsere Mitarbeitenden steht dabei felsenfest: Wir wachsen gemeinsam, haben Freude an unserer Arbeit und inspirieren uns gegenseitig. **Willkommen bei Bosch.**Als...

  • Project Safety Manager

    vor 1 Woche

    Wien, Wien, Österreich Bosch Group Vollzeit

    UnternehmensbeschreibungBei Bosch gestalten wir Zukunft mit hochwertigen Technologien und Dienstleistungen, die Begeisterung wecken und das Leben der Menschen verbessern. Unser Versprechen an unsere Mitarbeitenden steht dabei felsenfest: Wir wachsen gemeinsam, haben Freude an unserer Arbeit und inspirieren uns gegenseitig. **Willkommen bei Bosch.**Als...

  • Quality/Compliance & Safety Manager

    vor 3 Wochen

    Wien, Wien, Österreich Oaklands Global Vollzeit

    Key ResponsibilitiesDirect reporting to the Accountable ManagerDevelopment, implementation, and maintenance of Quality/Compliance Monitoring Program and Management System.Liaison with competent CAA aviation authorities.Management of findings and noncompliance reports.Audit planning and execution according to international and regulatory...

  • Quality/Compliance & Safety Manager

    vor 2 Monaten

    Wien, Wien, Österreich Oaklands Global Vollzeit

    Key ResponsibilitiesDirect reporting to the Accountable ManagerDevelopment, implementation, and maintenance of Quality/Compliance Monitoring Program and Management System.Liaison with competent CAA aviation authorities.Management of findings and noncompliance reports.Audit planning and execution according to international and regulatory...

  • Safety and Security Risk Manager

    vor 1 Woche

    Wien, Wien, Österreich Caritas Österreich Vollzeit

    What you will do: Work with the Emergency Response Team and Europe Team to develop, evaluate, review and update the Ukraine Local Safety and Security Plans. Work with the Emergency Response Team and Europe Team to develop, review and implement standard operating procedures and contingency plans. Work with the Emergency Response Team and Europe Team to...

  • Safety Manager Business Area Pulp

    vor 1 Woche

    Wien, Wien, Österreich ANDRITZ AG Vollzeit

    Job family: QHSE Management- Business area: Andritz Group- Contract location: Raaba-Grambach, Styria, AT Vienna, Vienna, AT- Working location: Raaba-Grambach, Styria, AT or Vienna, Vienna, AT- Location type: Office Location / Office-based- Contract type: Permanent Full-Time- Job description:Every day, ANDRITZ continues to deliver successful innovative...

  • Nuclear Safety Officer(P4)

    vor 1 Woche

    Wien, Wien, Österreich International Atomic Energy Agency Vollzeit

    Nuclear Safety Officer(P / Organization: NSNI-External Events Safety SectionPrimary Location: Austria-Vienna-Vienna-IAEA HeadquartersJob Posting: , 7:02:19 AMClosing Date: , 4:59:00 PMDuration in Months: 36Contract Type: Fixed Term - RegularProbation Period: 1 YearFull Competitive Recruitment: YesOrganizational Setting The Department of Nuclear Safety and...

  • HEALTH & SAFETY MANAGER (M/W/D)/ ISO 45001 Implementation Project

    vor 1 Woche

    Wien, Wien, Österreich ZARA Vollzeit

    Inditex Austria - Zara, Bershka, Pull&Bear, Massimo Dutti & Zara Home bieten attraktive Arbeitsplätze in einem trendigen Umfeld und einem erfolgreichen und stark expandierenden Unternehmen. Motivierte Teams, Weiterbildungen, sehr gute Karrierechancen und Innovation zeichnen uns als Top-Arbeitgeber aus. Möchtest Du Teil unseres Teams werden und uns helfen,...

  • Nuclear Safety Officer(P4)

    vor 1 Woche

    Wien, Wien, Österreich International Atomic Energy Agency Vollzeit

    Nuclear Safety Officer(P / Organization: NSNI-Regulatory Activities SectionPrimary Location: Austria-Vienna-Vienna-IAEA HeadquartersJob Posting: , 7:19:48 AMClosing Date: , 4:59:00 PMDuration in Months: 36Contract Type: Fixed Term - RegularProbation Period: 1 YearFull Competitive Recruitment: YesOrganizational Setting The Department of Nuclear Safety and...

  • Nuclear Safety Officer(P4)

    vor 1 Woche

    Wien, Wien, Österreich International Atomic Energy Agency Vollzeit

    Nuclear Safety Officer(P / Organization: NSNI-Safety Assessment SectionPrimary Location: Austria-Vienna-Vienna-IAEA HeadquartersJob Posting: , 1:42:44 AMClosing Date: , 4:59:00 PMDuration in Months: 36Contract Type: Fixed Term - RegularProbation Period: 1 YearFull Competitive Recruitment: YesOrganizational SettingThe Department of Nuclear Safety and Security...

  • Department Manager:in Safety Management

    vor 1 Woche

    Wien, Wien, Österreich ÖBB-Holding AG Vollzeit

    Wir möchten neue Wege gehen. Und neue Wege schaffen. Heute. Für morgen. Für uns.Werden auch Sie Teil des #Team ÖBB.Damit wir auch morgen End-to-end Logistiklösungen für jede Industrie anbieten können, um einen umweltfreundlichen Gütertransport zu ermöglichen. Wir, das sind rund 6.000 Möglichmacher:innen der Rail Cargo Group einem der führenden...

  • Technical Safety Investigator

    vor 1 Woche

    Wien, Wien, Österreich DHL Express Vollzeit

    (240013N) Austria-WienVienna | Fulltime | Permanent | Mixed ShiftWould you like to become part of the world's most international company?A company that pioneered cross-border express delivery in 1969 and is now active in more than 220 countries and territories worldwide. Do you want to be part of a company that connects people worldwide? And the more people...

  • Technical Safety Investigator

    vor 1 Woche

    Wien, Wien, Österreich DHL Vollzeit

    Would you like to become part of the world's most international company?:A company that pioneered cross-border express delivery in 1969 and is now active in more than 220 countries and territories worldwide. Do you want to be part of a company that connects people worldwide? And the more people we connect, the better life will be on our planet.Do you want to...