Pharmacovigilance Manager II

Responsibilities

• Support the Country Safety Head in ensuring local PV activities comply with global, regional, and local regulations in Brazil.
• Build and maintain strong cross-functional collaboration with Medical, Regulatory, Quality, Commercial, and Legal teams.
• Lead the local implementation of Risk Management Plans (RMPs) and execute risk minimization strategies.
• Support local safety surveillance, including signal detection, monitoring safety communications, and ensuring timely escalation to health authorities.
• Manage local periodic reports (e.g., PSRs) end-to-end, including planning, development, and submission.
• Participate in due diligence for acquisitions and divestments by assessing safety profiles and reviewing SDEAs.
• Act as a Local Safety Officer (LSO) when required, leading safety analyses and defining risk minimization actions.

Requirements

• Experience in Pharmacovigilance or related pharmaceutical disciplines such as Medical Affairs, Quality Assurance, or Regulatory Affairs.
• Progressive experience in managerial roles.
• Demonstrated expertise in developing high-quality safety documentation, including RMPs, PBRERs, and signal detection reports.
• Strong leadership capabilities with experience directing multidisciplinary teams.
• Bachelor's degree in Health Sciences, Pharmacy, or a Medical Doctor degree (other medical or scientific backgrounds may be considered).
• Professional English language proficiency and conversational Portuguese.

Preferred Qualifications

• Proven track record of effective stakeholder engagement and regulatory liaison with national and international agencies.
• Advanced analytical skills with expertise in interpreting clinical and post-marketing data.
• Experience operating effectively within global, matrix, and cross-functional team environments.

About the Company

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Through a deep understanding of the immune system and an innovative pipeline, we invent medicines and vaccines that treat and protect millions of people around the world.