Global Pharmacovigilance Aggregate Reporting Manager

2 semanas atrás

São Paulo, São Paulo, Brasil Kenvue Tempo inteiro

Job Summary

We are seeking a highly skilled Global Pharmacovigilance Aggregate Reporting Manager to join our team at Kenvue. As a key member of our Pharmacovigilance department, you will be responsible for ensuring timely and quality reports/safety analyses related to core deliverables.

Key Responsibilities

  • Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development
  • Provide oversight of staff involved in aggregate reporting
  • Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products, to assure regulatory compliance with company standards and regulatory requirements
  • Initiate/Conduct/Oversee searches of internal and external databases
  • Perform management review of all vendor-produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review
  • Author, contribute, and coordinate the preparation of core safety deliverables
  • Prepares global aggregate reports for local authorities
  • Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable
  • Partner with vendor to develop reports/deliverables
  • Develop 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 and implement necessary changes to processes and procedures.
  • 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, global regulations/guidelines by either onsite or offshore resources.
  • Performs training, onboarding, and oversight of offshore vendor.
  • Participate or lead department and/or cross-functional initiatives.
  • Contributes metrics and ensures quality, compliance, and timeliness of aggregate safety reports.

Requirements

  • Bachelor's degree required (health/life sciences field)
  • 5 years of experience in the pharmaceutical or related industry with 2 years of experience in Pharmacovigilance
  • Proven experience working in matrix environment and cross-functional teams
  • Comprehensive clinical/medical writing experience
  • Strong English verbal and written communication skills
  • Strong 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.

Preferred Qualifications

  • Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred
  • Strong 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; knowledge and hand-on experience in aggregate reports writing and compliance management.
  • In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies.

About Kenvue

Kenvue is a global healthcare company that is passionate about delivering innovative solutions to improve patient outcomes. We are committed to advancing the science of everyday care and are seeking talented individuals to join our team.

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