Manager, Global Pharmacovigilance Aggregate Reporting BRL 80.000 - 120.000 Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.Job Description - Manager, Global Pharmacovigilance Aggregate Reporting (2407026741W)This position reports into the Associate Director, GARRM Team Lead and is based in Sao Paulo, Brazil.Who we areAt Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.Role reports to:Travel %:10What you will doThe Manager, Global Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate reports, Risk Management Plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports within Medical Safety for Kenvue products. The Manager provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training.Key ResponsibilitiesEnsure timely, quality reports/safety analyses related to core deliverables as appropriate:Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy developmentProvide oversight of staff involved in aggregate reportingDevelop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer productsInitiate/Conduct/Oversee searches of internal and external databasesPerform management review of all vendor-produced materialsAuthor, contribute, and coordinate the preparation of core safety deliverablesPrepares global aggregate reports for local authoritiesEnsure compliance and commitments are metPartner with vendor to develop reports/deliverablesDevelop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements.Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports.Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting.Stay up-to-date with regulatory changes and industry trends related to pharmacovigilance aggregate reporting.Develop and maintain systems, tools and processes for drug safety operations.Participate and/or lead cross-functional training of relevant stakeholders and colleagues.Act as product or process Subject Matter Expert (SME) during audits/inspections.Daily management of vendor activities and responsibility for compliance with SOPs/WIs.Participate or lead department and/or cross-functional initiatives.Contributes metrics and ensures quality, compliance, and timeliness of aggregate safety reports.QualificationsWhat we are looking forRequired QualificationsBachelor's degree required (health/life sciences field)= 5 years of experience in the pharmaceutical or related industry with = 2 years of experience in PharmacovigilanceProven experience working in matrix environment and cross-functional teamsStrong English verbal and written communication skillsStrong knowledge of global pharmacovigilance regulations and guidelines (i.e., ICH, GVP, etc.).Ability to work collaboratively with cross-functional teams.Strong analytical and problem-solving skills.Desired QualificationsAdvanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferredStrong leadership and presentation skills.Experience in developing and implementing drug safety policies and operating procedures.Ability to work in a fast-paced environment and manage multiple projects simultaneously.SME with in-depth product knowledge of assigned products.In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies.What's in it for youPaid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!Employee Resource GroupsKenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#J-18808-Ljbffr