Pharmacovigilance Specialist

Há 7 dias


São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro
Job Summary

Johnson & Johnson is seeking a highly skilled Pharmacovigilance Specialist to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety of our products and compliance with regulatory requirements.

Key Responsibilities
  • Reporting and Compliance: Ensure that all Pharmacovigilance activities are in compliance with local regulations and company policies/procedures.
  • Case Processing: Manage and maintain active involvement in day-to-day AE reporting, including collection, review, reporting, and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs), and pregnancy reports.
  • Translation and Oversight: Translate ICSR, PSUR, Health Authority (HA) correspondence, regulatory intelligence, as required, and provide oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs.
  • Clinical Trial Compliance: Collaborate with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to GMS or appropriate case management center and HA.
  • Signal Detection and Aggregate Reporting: Reporting of potential single case signals or clusters of similar events seen in case processing, and plan and ensure timely submission of Aggregate Reports according to local regulations.
  • Business Continuity and Risk Management: Creation and implementation of business continuity plans, ensure an effective system is in place for 24-hour coverage, and have an appropriate system of PV and Risk Management in place to assure appropriate oversight for the implementation of Risk Management Activities.
Requirements
  • Strong knowledge of Pharmacovigilance regulations and guidelines.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong analytical and problem-solving skills.
  • Proficiency in Microsoft Office and ability to learn new software systems.


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