Job Description

Work Your Magic with us! Ready to explore, break barriers, and discover more We know you\'ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That\'s why we are always looking for curious minds that see themselves imagining the unimaginable with us. 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. The PharmacovigilanceBusiness ProcessWriting Lead will be responsible for the creation of high-quality Pharmacovigilance (PV)-related Quality Documents (QDs) in alignment with the respective Process Owners.He/she will lead Business Process Management (BPM) strategy and implementation in Global Patient Safety (GPS) ensuring a fit for purpose BPM landscape and respective QDs. QDs encompass documents such as Policies, Standards, Standard Operating Procedures, and Working Instructions, as well as guidance documents. Your role: For our global PV QDs he/she will ensure content quality, compliance with applicable regulations and Company internal rules and timely availability by applying the BPM methodology. Key PV processes include but are not limited to areas like Aggregate Reports, Risk Management, Signal Management, Emerging Safety Issues, Urgent Safety Restrictions, Direct Health Care Professional Communication, Safety Communication, Post-Authorization Safety Studies and PV Quality System. In addition, he/she will ensure that PV requirements are fully implemented in non-GPS QDs in adequate quality and compliance with applicable regulations through provision of high-quality reviews including a system and oversight for qualified reviewers/review on behalf of GPS. Provide leadership for implementation of automated solutions for structured content writing as well as leading implementation of structured content writing for PV Quality Management System related documents, for example the Pharmacovigilance System Master File. To fulfill the role of the Deputy for the GPS Head of Documentation and Training within the PV System and QPPV function. Who you are: University degree in natural science, pharmacy or equivalent education with project management experience Strong process orientation and demonstrated professional experience in QD writing Excellent command of MS Office suite 8-10 years of experience of working preferably in Pharmacovigilance (PV), but could also include work experience in the R&D environment as a part of the Pharmaceutical or Biotech industry. Experience in PV should include understanding of the broad scope of PV systems and end-to-end PV processes including medical safety, and cross-functional interactions both within and outside PV. Additional experience in Medical Writing or Quality Assurance is advantageous. Fluent professional English required additional EU languages appreciated Excellent knowledge of GxP quality systems and safety-related regulations (clinical trials and post-marketing, EU and worldwide), Demonstrated practical experience of managing compliance with regulatory standards and requirements Rigorous approach to quality and compliance with attention to detail, personal effectiveness and performance/output driven, Strong intercultural skills (developed from practical experience of international working), strong team-working skills - working across cultural and functional boundaries as well as virtual working experience, Excellent problem-solving ability and negotiation skills, Excellent organizational skills, ability to prioritize work and adapt to changing priorities, Ability to remain calm under pressure and maintaining clear thinking and communication 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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

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