Signal Management Strategy Lead (all genders)

Posté 21 juin 2022

Darmstadt, Hessen - Germany

Demander un identifiant 250640

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role:

The Signal Management Strategy Lead reports into the head of Benefit-Risk Strategy & Management within our Global Patient Safety (GPS) organization and is the Business Process Owner (BPO) of the signal management process. In this role you are responsible for the strategic alignment and development of processes as well as process execution. This role also acts as the interface between functional management and performing process roles. Furthermore, you are accountable for the development of tools, visualizations, and analytics to support decision making of the safety and cross functional teams in the context of detection, validation, assessment, and communication of safety signals, and Benefit Risk Assessment & Management. Key responsibilities will include taking ownership and acting as the single point of contact with full accountability for the process. This includes defining process goals, identifying requirements, process elaboration, maintenance of consistent and up-to date documentation, identification and mitigation of process-related risks, planning changes, and continuous improvement. As BPO, you make process-related decisions and necessary measures to ensure that process objectives are met and that regulatory requirements are adhered to. You ensure effectiveness (delivery of the defined process output), efficiency and compliance with regulations and requirements. You align with line managers and process participants within GPS/cross functionally and implement optimization measures in business, balancing time/cost/quality considerations resulting in optimal process efficiency. In collecting feedback you identify further areas of improvement and maintain oversight on the execution of every aspect of the signal management process providing oversight to line management and relevant collaborators.

 

Who you are:

  • Master degree (PhD preferred) in medicine, pharmacy, or biology

  • 5-10 years experience in the Pharmaceutical Industry, with at least 5 years in Pharmacovigilance (PV), with meaningful experience of regulatory inspections and follow-up actions with CAPA plans. Quality experience is a plus.

  • Proven experience of Good Pharmacovigilance Practice (GVP) and other good practice guidelines within the European regulatory environment

  • Knowledge and understanding of PV regulations worldwide

  • Excellent knowledge of capturing PV information and its analysis, evaluation and visualization

  • Knowledge and experience in software development, testing, and validation (e.g., Empirica, Spotfire)

  • Experience working in a cross functional matrix

  • Strong communication and presentation skills; proficient in Microsoft Office

  • Excellent interpersonal skills

  • Excellent ability to prioritize and coordinate tasks

  • Fluent in written and spoken English


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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