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• At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Product Safety Job Sub Function: Product Safety Risk Management Job Category: Scientific/Technology All Job Posting Locations: Porto Salvo, Portugal Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine. Johnson & Johnson is recruiting for a Senior Aggregate Report Scientist based in Lisbon, Portugal. Position Summary Join us as a Senior Aggregate Report Scientist and play a pivotal role in the post-marketing safety landscape! You will lead the development and production of critical aggregate safety reports, collaborating closely with cross-functional teams to ensure data accuracy, regulatory compliance, and clear communication of the benefit-risk profile of our products. Our collective expertise in pharmacovigilance, medical writing, and global safety regulations will be essential in interpreting complex data, addressing health authority requests, and influencing safety decisions. This role offers the opportunity to contribute to impactful safety assessments, foster strategic partnerships, and support continuous improvement within a dynamic, global environment. Duties and Responsibilities The Senior Aggregate Report Scientist (ARS) will support the scheduled post-marketing aggregate report deliverables and work in close collaboration with other partners to collect, interpret, and incorporate data from a variety of sources into the reports to properly communicate the benefit-risk of the product. In this role, you will show knowledge of the industry regulations and guidance for scheduled aggregate reports and a broad understanding of content needed for the reports. You will serve as product point of contact and lead cross-functional teams in producing the scheduled aggregate reports, providing guidance on content, processes, timelines, and scientific integrity to ensure well-written reports. In addition, you will function independently, link discussions to content, and deliver quality results with some support from more senior team members. You will build alliances and be able to influence safety partners to shape decisions and outcomes. The Senior ARS will be responsible for aggregate report preparation including: Developing knowledge of pharmacovigilance (PV) regulations and purpose of the scheduled aggregate reports. Effectively partnering with teams such as Global Medical Safety staff, vendors, and regulatory, and owning the production of the scheduled aggregate report to ensure high quality safety reports and to optimize data retrieval. Ensuring Health Authority (HA) requests/Assessment Reports have been addressed as required Reviewing and/or writing safety topics 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. You will also have the chance to participate in department and/or cross-functional initiatives. Minimum Qualification Bachelor’s Degree Required: Healthcare-related or Biomedical Science (4+ years industry experience or equivalent). Advanced Degree Preferred: Healthcare-related or Biomedical Science (2+ years industry experience or equivalent). Medical writing or PV experience is expected. Clinical experience preferred. Required Skills: Knowledge of global regulatory framework for aggregate safety reports & experience in developing aggregate safety reports such as Periodic Benefit-Risk Evaluation Report. 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 complex medical-scientific data from a broad range of subject areas. Ability to interpret and present complex data to determine benefit-risk impact. Excellent English verbal and written communication skills. Ability to effectively interact with stakeholders, including business partners. Ability to work in a matrix environment, proven leadership skills. Ability to plan work to meet deadlines and effectively handle multiple priorities. Ability to influence, negotiate and connect with both internal and external customers. Required Skills: Preferred Skills: Clinical Operations, Coaching, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, OSHA Compliance, Quality Control (QC), Researching, Risk Compliance, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing, Technologically Savvy At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information