Senior Pharmacovigilance Officer

vor 3 Monaten

Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit

**YOUR CONTRIBUTION**

Join our Pharmacovigilance Group within Global Product Safety and grow with new challenges. Your scope of work with us will include the following tasks:

- As Deputy EU/UK QPPV and Deputy Graduated Plan Officer (“Stufenplanbeauftragter”), you will maintain the oversight of the timely preparation and maintenance of essential documents in the area of pharmacovigilance, such as the PV System Master File, safety reports (e.g. PSURs, RMPs), contractual agreements with license/distribution partners and service providers, work instructions etc.

Maintaining and shaping the international pharmacovigilance (PV) system for all drugs of Merz Therapeutics including Merz Entities, license/distribution partners and service providers of Merz Therapeutics focusing on maintaining information channels, responsibilities, and work processes in collaboration with the QPPV and the "Stufenplanbeauftragter".

Accompanying and monitoring of risk and referral procedures and coordination of the resulting measures, e.g. recalls / risk defenseActive preparation and participation in PV audits and PV inspections and to ensure the implementation of resulting Corrective and Preventive ActionsCreation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)Commissioning and supervision of vigilance service providers for outsourced vigilance activities as well as preparation and updating of the corresponding contracts.
- Creating and updating Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide

**YOUR PROFILE**- Licensed pharmacist or comparable scientific education (e.g. Diploma or Master of Science- Experience as Deputy Commissioner of the Graduated Plan and/or Deputy EU/UK QPPV
- Several years of experience in pharmacovigilance and understanding of PV legislation in Germany, Europe, and the UK (e.g., AMG, AMWHV, GVP)

Knowledge in the field of Regulatory Affairs for medicinal products is necessaryRegular further training with regard to current developments in the field of drug safety / PV and Good Pharmacovigilance Practice; experience with the practical implementation of the requirements thereofFluent in written and spoken English and strong communication skillsStrong analytical skills and ability to work scientificallyVery careful, conscientious way of working and ability to work in a teamHigh level of resilience and self-organization
- Confident handling of Microsoft Office package, if necessary knowledge in handling drug safety databases

**YOUR BENEFITS**
- Individual career development in a purposeful job: you improve the quality of life of our patients
- Hybrid work model that allows a good work-life balance
- Attractive location with good transport links, modern workplaces and a company restaurant (€3.80/menu)
- Global family business with flat hierarchies and an open, respectful corporate culture
- Attractive remuneration with extensive social benefits
- Variety of employer-subsidized benefits such as Wellpass (€17.90/month), Germany ticket (10€/month), Corporate Benefits and JobBike

**Find out more about our benefits **here**.**

**ABOUT US**

**Welcome to Merz Therapeutics**,** a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.

**We are proud** to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.

**Our goal **is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

**Our dedication and commitment** to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal:
**"BETTER OUTCOMES FOR MORE PATIENTS"

  • Senior Pharmacovigilance Professional

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Pharmacovigilance Expert WantedWe are seeking a highly skilled Senior Pharmacovigilance Officer to join our team at Merz Therapeutics, a leading pharmaceutical company dedicated to improving treatment outcomes for patients worldwide.This role offers a unique opportunity to grow with new challenges and contribute to the quality of life of our patients....

  • Pharmacovigilance Expert in Global Drug Safety

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Pharmacovigilance Officer RoleWe are seeking a skilled Pharmacovigilance Officer to join our team at Merz Therapeutics.About the JobThe successful candidate will be responsible for maintaining and shaping the international pharmacovigilance system for all drugs of Merz Therapeutics, including Merz Entities, license/distribution partners, and service...

  • Junior Pv Officer

    vor 6 Monaten

    Frankfurt am Main, Deutschland PrimeVigilance Vollzeit

    **Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

  • (Senior) Patient Safety Physician Inflammation

    vor 6 Monaten

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you passionate about patient health and safety? If yes, we have an exciting opportunity for you! **Tasks & Responsibilities**: - In this role as a (Senior) Associate Director / (Senior) Patient Safety Physician for Inflammation, you will lead or contribute to the global Patient Safety and Pharmacovigilance (PSPV) and Risk Management...

  • (Senior) Patient Safety Physician CRM

    vor 6 Monaten

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you passionate about patient health and safety? If yes, we have an exciting opportunity for you! Our dedicated TA CRM Team is seeking experienced (Senior) Patient Safety Physicians to join us on our journey. You'll have the chance to work on a variety of products, either in clinical development or post-marketing drug safety. We're...

  • (Senior) Patient Safety Physician Crea

    vor 6 Monaten

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you passionate about patient health and safety? If yes, we have an exciting opportunity for you! Our dedicated Patient Safety teams are seeking experienced (Senior) Patient Safety Physicians to join us on our journey. You'll have the chance to work on a variety of products, either in clinical development or post-marketing drug safety....

  • Senior Proposals Associate

    vor 6 Monaten

    Frankfurt am Main, Deutschland PrimeVigilance Vollzeit

    **Company Description** We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...

  • Senior Information Security Officer

    vor 6 Monaten

    Frankfurt am Main, Deutschland Personal Direkt Vollzeit

    Wir besetzen seit 1994 vakante Personalanforderungen bei unseren Kunden in unseren Beratungsfeldern der steuerberatenden Berufe, Banking, Legal & Office und Real Estate. Für eine internationale Geschäftsbank in Frankfurt am Main suchen wir eine/n: **Senior Information Security Officer (gn)**: **Ihre Aufgaben**: - Sie fungieren in der Stabsstelle als...

  • Deputy Compliance Officer

    vor 3 Wochen

    Frankfurt am Main, Deutschland Michael Page Vollzeit

    Deputy Compliance Officer (m/w/d) Senior ManagerThe Senior Manager will act as the Deputy Compliance...

  • Deputy Compliance Officer

    vor 3 Wochen

    Frankfurt am Main, Deutschland Michael Page Vollzeit

    Deputy Compliance Officer (m/w/d) Senior ManagerThe Senior Manager will act as the Deputy Compliance...

  • Senior Financial Officer

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Finance in Motion Vollzeit

    About UsFinance in Motion is a global impact asset manager that focuses on sustainable development in low and middle-income countries.We develop and advise impact investment funds that bring together public and private investors to address climate change, strengthen biodiversity conservation, foster the sustainable use of natural resources, improve...

  • Senior Legal Officer

    vor 6 Monaten

    Frankfurt am Main, Deutschland Citco Vollzeit

    **Senior Legal Officer** **Frankfurt, Germany. **About Citco**: For more than 75 years, we have been at the forefront of the corporate services industry, serving dynamic companies with sharp thinking, foresight, and unmatched expertise. That tradition continues today and into the future as we carve new paths and help shape the future of our...

  • Senior Compliance Officer

    vor 7 Monaten

    Frankfurt am Main, Deutschland PICTET Vollzeit

    **Your team**: - Nach dem erfolgreichen Aufbau ihres europäischen Hauptsitzes in Frankfurt am Main verstärkt die Bank Pictet & Cie (Europe) AG (BPAG) ihr europäisches und deutsches Compliance-Team in Frankfurt am Main mit einem Senior Compliance Officer (WpHG / MaComp) / L2 Single Officer.- Diese Position bietet die Chance, in einer spannenden Zeit am...

  • Business Development Director

    vor 6 Monaten

    Frankfurt am Main, Deutschland PrimeVigilance Vollzeit

    Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...

  • Office Administrator

    vor 7 Monaten

    Frankfurt am Main, Deutschland ATC Computer Transport & Logistics Vollzeit

    ATC ist ein europäischer Spezialist für Logistik, White Glove und technische Dienstleistungen für Rechenzentren. Wir legen besonderen Wert darauf, die kritischen Anforderungen unserer Kunden früh und genau zu verstehen und Lösungen für sie zu entwickeln, die branchenführende Standards erfüllen. Seit unserer Gründung im Jahr 1979 haben wir mit...

  • (Senior) Planning

    vor 7 Monaten

    Frankfurt am Main, Deutschland Pictet & Cie (Europe) Vollzeit

    . Company description: The Pictet Group is one of the world’s leading independent wealth and asset managers. Founded in 1805 and headquartered in Geneva, Switzerland, the Group is represented at 30 offices in financial centres worldwide, and currently employs over 5200 people. After successfully establishing the Bank’s European headquarters in...

  • Senior Compliance Advisory Officer

    vor 8 Monaten

    Frankfurt am Main, Deutschland Apollo Solutions Vollzeit

    A prestigious and long-standing private bank is looking for an experienced Compliance Advisory Manager/Officer to join a growing compliance function and provide advice to their investment banking arm. Some of your tasks will be: - Providing advice and regulatory guidance to the investment banking business, specifically the Investment Banking Continental...

  • Senior Finanzexperte für Luftfahrtunternehmen

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland DIS AG Vollzeit

    Wir suchen im Rahmen der Personalvermittlung zum nächstmöglichen Zeitpunkt einen (Senior-) Finanzexperten in Festanstellung für den Standort Frankfurt. Unsere Kunden sind weltweit tätige Unternehmen, die auf die Organisation von Flugzeugchartern für Fracht- und Passagiertransporte spezialisiert sind.Als Senior Finanzexperte werden Sie Teil unseres Teams...

  • Senior Credit Officer

    vor 2 Monaten

    Frankfurt am Main, Deutschland Deutsche Bank Vollzeit

    **Senior Credit Officer (f/m/x)**: **Job ID**:R0350845**Full/Part-Time**:Full-time**Regular/Temporary**:Regular**Listed**:2024-10-09**Location**:Frankfurt**Position Overview**: **Details of the role and how it fits into the team** CRM is an independent approval and monitoring function for credit exposure within the entire DB group. The transaction team for...

  • Senior Risk Management Officer

    vor 5 Monaten

    Frankfurt, Deutschland Crypto Finance AG Vollzeit

    About Crypto Finance GroupThe Crypto Finance Group comprises two FINMA-regulated financial institutions and a BaFin-regulated subsidiary in Germany. As part of Deutsche Börse Group, Crypto Finance AG provides professional digital asset solutions to institutional clients. This includes one of the first FINMA-approved securities firms offering 24/7 brokerage...