PV Compliance Expert

Há 6 dias

São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro R$90.000 - R$130.000

Job Title: Pharmacovigilance Compliance Leader

Job Summary:

We are seeking a highly skilled and detail-oriented PV Compliance Leader to strengthen our global Pharmacovigilance Quality Team.

The ideal candidate is passionate about driving compliance and continuous improvement, and has a strong understanding of Good Vigilance Practices, a proactive mindset, and the ability to collaborate across global functions.

Key Responsibilities:
  • Maintain and continually improve a suite of lean PV operating procedures that can be consistently applied across the organisation
  • Design and implement supporting PV training and awareness initiatives
  • Continuous monitoring of the effectiveness of the QMS through deviation management, audit outcome, KPI reporting, management review, and authority inspection support to drive strategic improvement.
Requirements:
  • Academic degree in life sciences; pharmacy or nursing preferred
  • Significant experience in Pharmacovigilance, Quality, or Regulatory activities within the Pharma/Life Sciences industry
  • Strong knowledge of GvP and global PV regulatory requirements
  • Proven experience in SOP writing, audit/inspection preparation, and CAPA management
  • Working knowledge of Safety and Deviation management databases
  • Exposure to working relationship with FDA, EMA and other regulatory authorities is an asset
  • Fluent in English (written and spoken); proficiency in other languages is an asset
  • Proficient in Microsoft Office, with strong Excel skills
Desired Skills:
  • Self-motivated with the ability to prioritize, schedule, and organize daily activities
  • Excellent communication and interpersonal skills: ability to communicate across organization levels and to connect with different audiences in a multicultural environment
  • Ability to work with interdisciplinary, highly matrixed teams and able to communicate complex messages. Good negotiating and influencing skills
  • Strong commitment to compliance with relevant regulations and procedures
  • Ability to set priorities and pivot as needed in a dynamic environment, ability to recognize time sensitivity
  • High integrity, flexibility, and willingness to travel occasionally

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