Deputy European Union

vor 5 Monaten

Frankfurt Am Main, Deutschland Lilly Vollzeit

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Interested? Then become part of our team and start as soon as possible as:
**Deputy European Union (EU) Qualified Person for Pharmacovigilance (M/F/d)**:
**What challenges await you?**
- Deputise for the European Union QPPV as required and according to delegation and specifically to fulfil the legal and regulatory requirements for the QPPV role in his or her absence.
- Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit.
- Play an active role in the GPS Leadership Team, Safety Review Committee (SRC) and other committees as required.
- Provide training /coaching /mentoring and demonstrating Global Patient Safety expertise and leadership.
- Deputise for the EU QPPV on the Global Product Labelling Committee (GPLC) as required.

**Primary Responsibilities**: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Deputise for the EU Qualified Person for Pharmacovigilance
- Fulfil the legal and regulatory requirements for the EU Qualified Person responsible for pharmacovigilance role as defined by prevailing European legislation and guidelines in the absence of the EU QPPV or as delegated by the EU QPPV.
- Ensure appropriate cover with the QPPV including provision of all the necessary information to fulfill the role.
- Maintain current awareness of the evolving EU regulatory environment, provide timely feedback to GPS leadership, and provide advice to the Medicines Quality Organisation as appropriate. Review and provide expert input to EU regulatory submissions PASS protocols and actions taken in response to emerging safety concerns in order to ensure appropriate risk minimisation and the timeliness, correctness and completeness of all pharmacovigilance data submitted to the Competent Authorities and to the European Medicines Agency (EMA).
- Provide QPPV input to GPLC in the absence of the QPPV or as delegated.
- Fulfill all other QPPV obligations as stipulated in the Good Vigilance Practice (GVP) guidelines as delegated by the QPPV.
- Play an active role in the GPS Leadership Team, SRC and other committees including GPLC as appropriate ; provide strategic and technical advice to these committees as well as to the global regulatory and medical organizations.
- Provide an independent expert viewpoint on specific safety issues.
- Maintain links with Global Regulatory Affairs and provide technical consultancy to safety sections of European regulatory submissions, responses to Committee for Medicinal Products for Human Use (CHMP)/other European regulatory authority safety questions, and guidance on safety sections of Summary of Product Characteristics, etc.
- Provide technical leadership through active external involvement in pharmacovigilance forums and bring shared learning back into the Lilly organization).
- Provide training, coaching and mentorship to safety surveillance scientists, and other Global Patient Safety Medical physicians and clinical research scientists and to other medical and regulatory functions in the MDU and business units as appropriate.

**How do you convince us?**

If you can look back on the following successes in your career to date, you bring the best prerequisites with you:

- Medical degree, and clinical experience
- Global focus; residency and operation in the EU/EEA
- A minimum of 5 years’ experience in pharmacovigilance; understanding of epidemiology principles is important.
- Problem solving skills, sound clinical judgement; decision making capability in pressurized circumstances
- Strong influencing, coaching, and negotiating skills across multiple internal and external audiences and levels of seniority
- Strong interpersonal, team working, writing, presentation, and communication skills
- Data-driven; ability to work effectively in a multi-cultural environment, team structure and independently
- Current awareness of product safety regulatory environment; ability to communicate and translate into company processes
- Broad knowledge of drug development and clinical research busine

  • European Finance Reporter

    vor 24 Stunden

    Frankfurt am Main, Deutschland Dow Jones Vollzeit

    European Finance Reporter The Wall Street Journal seeks a reporter to cover the heart of the European financial system from Frankfurt, Germany. We want an aggressive reporter who is innately curious about the world of money—who’s making it, who’s losing it, who’s stealing it. You know how monetary policy impacts markets and investors. You can...

  • European Finance Reporter

    Vor 4 Tagen

    Frankfurt am Main, Deutschland Dow Jones Vollzeit

    European Finance Reporter The Wall Street Journal seeks a reporter to cover the heart of the European financial system from Frankfurt, Germany. We want an aggressive reporter who is innately curious about the world of money—who’s making it, who’s losing it, who’s stealing it. You know how monetary policy impacts markets and investors. You can...

  • European Finance Reporter

    vor 3 Monaten

    Frankfurt am Main, Deutschland Dow Jones Vollzeit

    European Finance Reporter The Wall Street Journal seeks a reporter to cover the heart of the European financial system from Frankfurt, Germany. We want an aggressive reporter who is innately curious about the world of money—who’s making it, who’s losing it, who’s stealing it. You know how monetary policy impacts markets and investors. You can...

  • European Finance Reporter

    vor 3 Monaten

    Frankfurt am Main, Deutschland Dow Jones Vollzeit

    European Finance Reporter The Wall Street Journal seeks a reporter to cover the heart of the European financial system from Frankfurt, Germany. We want an aggressive reporter who is innately curious about the world of money—who’s making it, who’s losing it, who’s stealing it. You know how monetary policy impacts markets and investors. You can...

  • Traineeships in Legal Services

    vor 2 Monaten

    Frankfurt am Main, Deutschland The European Central Bank Vollzeit

    **General Information*** **Type of contract** Traineeship **Who can apply?** EU nationals eligible for our traineeship programme **Grant** The trainee grant is €1,170 per month plus an accommodation allowance (see further information section) **Working time** Full time **Place of work** Frankfurt am Main, Germany **Closing date** 05.11.2024 **Your...

  • Traineeships in Legal Services: Expertise Development

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland European Central Bank Vollzeit

    Job Role and ResponsibilitiesYou will be assigned to one of the three divisions: Institutional Law, Financial Law, or Supervisory Law.As a trainee in the Institutional Law Division, you will: Assist in preparing legal advice on central banking law, the ECB's privileges and immunities, EU law, contracts, and procurement law. Handle legal issues concerning...

  • Imi Cib

    vor 3 Monaten

    Frankfurt am Main, Deutschland Intesa Sanpaolo Group Vollzeit

    Intesa Sanpaolo is the banking group leader in Italy. Assisting more than 14,6 milion of retail customers through a network of 5360 branches, it significantly supports the development of Companies and gives an important sustain to the country's growth. The Group has a selected retail banking presence in Central and Eastern Europe, the Middle East and North...

  • Project Specialist, European Directives and Standards

    vor 6 Monaten

    Frankfurt, Deutschland CSA Group Vollzeit

    Employment Status: Regular Time Type: Full time BUILDING A WORLD CLASS TEAM STARTS WITH YOU At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500...

  • Project Specialist, European Directives and Standards

    vor 6 Monaten

    Frankfurt, Deutschland CSA Group Vollzeit

    Statut d'emploi: Permanent Type d'heures: À temps plein Nous avons besoin de vous pour former une équipe de calibre mondial Les activités du Groupe CSA reposent sur l’atteinte d’un idéal : rendre le monde meilleur, plus sûr et plus durable.Cet ideal est au coeur de notre mission depuis 1919, année où nous avons élaboré notre première...

  • Traineeships in Legal Services

    vor 1 Monat

    Frankfurt, Deutschland European Central Bank Vollzeit

    Your role You will be assigned to one of the three divisions mentioned above. You will carry out research and prepare legal advice in close collaboration with experienced legal counsels.As a trainee in the Institutional Law Division, you will: help prepare legal advice on questions relating to central banking law, the ECB’s privileges and immunities,...

  • Director General On-site

    vor 2 Monaten

    Frankfurt am Main, Deutschland The European Central Bank Vollzeit

    **General Information*** **Who can apply?** EU nationals **Salary** L full time monthly net salary: €13,277 plus benefits, for further information see what we offer. **Role specialisation** Leadership **Working time** Full time **Place of work** Frankfurt am Main, Germany **Closing date** 07.10.2024 **Your team*** - Since 2014 the ECB has been...

  • AFC Audit Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Raisin GmbH Vollzeit

    Role OverviewRaisin GmbH is establishing a Group Internal Audit function to support the Management in protecting the company's assets, reputation, and sustainability. The Group Internal Audit function will provide independent, objective assurance and consulting services to add value and improve operations. The team will help Raisin accomplish its objectives...

  • Corporate Treasury Cio

    vor 5 Monaten

    Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** You will work in partnership with senior management, developing and implementing the liquidity and structural interest rate risk strategy for JP Morgan Chase’s primary entity in the European Union. This position is a rare opportunity to work in a fast paced, international team managing a €400bn balance sheet. As a Corporate Treasury...

  • Deputy Team Lead Credit Management

    vor 2 Monaten

    Weil am Rhein, Deutschland Carhartt Work in Progress Vollzeit

    -Carhartt WIP is part of the WIP Trading AG. Our family-owned business group started as a licensee and European distributor of the US workwear manufacturer Carhartt in the early 1990s. Since then, it develops its own collections based on workwear originals. Carhartt Work In Progress aims to continuously progress and evolve, without ever losing sight of its...

  • Senior Economist

    vor 3 Monaten

    Frankfurt am Main, Deutschland The European Central Bank Vollzeit

    **General Information*** **Contract end date** 31.12.2027 **Who can apply?** EU nationals working for national central banks of the ESCB, international governmental organisations or other employers performing central banking or banking supervision tasks within the framework of the Eurosystem **Salary** F/G (bracket 2 - step 1) full time monthly net...

  • Multimedia Specialist

    vor 3 Monaten

    Frankfurt am Main, Deutschland The European Central Bank Vollzeit

    **General Information*** **Who can apply?** EU nationals **Salary** E/F (bracket 1 - step 1) full time monthly net salary: €4,611 plus benefits, for further information see what we offer. **Role specialisation** Multimedia **Working time** Full time **Place of work** Frankfurt am Main, Germany **Closing date** 23.09.2024 **Your team*** - You will be...

  • Corporate Treasury CIO

    vor 1 Monat

    Frankfurt am Main, Deutschland JPMorganChase Vollzeit

    Job DescriptionYou will work in partnership with senior management, developing and implementing the liquidity and structural interest rate risk strategy for JP Morgan Chase’s primary entity in the European Union. This position is a rare opportunity to work in a fast paced, international team managing a €400bn balance sheet.As a Corporate Treasury CIO...

  • Quality Assurance Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

    Quality Assurance Manager / Deputy Technical DirectorGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110...

  • Sachbearbeiter in

    vor 6 Monaten

    Frankfurt am Main, Deutschland DOSB Vollzeit

    MAKKABI Deutschland e. V. sucht für das Büro in Frankfurt/Main ab sofort eine/einen Sachbearbeiter*in (w/m/d) Finanzen/Verwaltung in Teilzeit (20 Std. pro Woche) **Deine Aufgaben**: - Erfassung von Rechnungen und Belegen - Nach Einarbeitung möglich: vorbereitende Buchhaltung - Pflege der Mitgliederdatenbank - Bestellwesen - Anmeldemanagement bei...

  • Jugendreferent in

    vor 6 Monaten

    Frankfurt am Main, Deutschland DOSB Vollzeit

    MAKKABI Deutschland e. V. sucht für das Büro in Frankfurt/Main oder Berlin **ab sofort** eine/einen **Jugendreferent*in (w/m/d) in Vollzeit (40 Std. pro Woche) **Deine Aufgaben**: - Aufbau und Betreuung der Jugendabteilung - Organisation nationaler und internationaler Jugend-Events - Überwachung und administrative Unterstützung der MAKKABI Deutschland...