Senior Aggregate Reports Scientist

le contenu du travail

Senior Aggregate Reports Scientist (ARS) Location: Office-based. Candidate can be based in either UK (High Wycombe), Belgium (Antwerp), France (Issy-les-Moulineaux), Sweden (Stockholm), Switzerland, US (Pensylvania, New Jersey) Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. As Senior Aggregate Reports Scientist (ARS) you will support the scheduled post-marketing aggregate report deliverables and work in close collaboration with other partners to collect, interpret, and incorporate multi-source data into the reports to accurately communicate the benefit-risk of the product. You’ll have basic knowledge of the industry regulations and guidance for scheduled aggregate reports and a broad understanding of content needed for the reports serving as product point of contact and lead cross-functional teams in producing scheduled aggregate reports, providing guidance on content, processes, timelines, and scientific integrity to ensure well-written reports. Functioning independently and linking discussions to content; delivering quality results with mentorship from more senior ARS to build alliances, shape outcomes and influence safety partners is key. The Senior ARS will be responsible for aggregate report preparation including: Developing knowledge of pharmacovigilance (PV) regulations and purpose of the scheduled aggregate reports Optimally partnering with partners (e.g., Global Medical Safety [GMS] staff, vendor, regulatory) and leading the production of the aggregate report to ensure high quality and optimal data retrieval Ensuring health authority (HA) requests/Assessment Reports have been addressed as required Reviewing and/or writing safety topics for reports for applicable products (e.g., Established Products) Interpreting and integrating information in a clear, concise manner Developing conclusions based on all information for applicable products Participate in cross-functional training of relevant stakeholders and contribute to training of ARS on activities within the role Participate in department and/or cross-functional initiatives This position reports into the Director, Aggregate Reports Team Lead and works closely with many groups including Global Medical Safety, Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, the vendor, and business partners. Qualifications Education & experience requirements: Bachelor’s Degree or equivalent in a healthcare or scientific area (6+ years industry experience or equivalent)! Advanced Degree Preferred in healthcare-related or biomedical scientific subject Medical writing or PV experience required (6-8 years)! Clinical experience preferred Required Skills: Knowledge of global regulatory framework for, and experience in developing, aggregate safety reports (e.g., PBRER) Solid understanding of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements Ability to understand and analyze sophisticated medical-scientific data from a broad range of subject areas Ability to interpret and present complex data to resolve benefit-risk impact Excellent English verbal and written communication skills Ability to work cross-functionally Ability to optimally handle multiple time-critical priorities Proficiency in Microsoft (e.g., Word, Excel, and PowerPoint) Ability to influence, negotiate and connect with both internal and external customers Primary Location United Kingdom-England-High Wycombe- Other Locations Europe/Middle East/Africa-France, Europe/Middle East/Africa-Belgium-Antwerp, Europe/Middle East/Africa-Sweden-Stockholm, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Horsham, United States-Pennsylvania-Horsham Organization Janssen Cilag Ltd. (7360) Job Function R&D Requisition ID 2105968835W