International Pharmacovigilance Senior Specialist

TL;DR

International Pharmacovigilance (PV) Senior Specialist: Supporting the management of global PV structures and ensuring regulatory compliance with an accent on Brazil and LATAM pharmacovigilance regulations. Focus on overseeing local Responsible Persons for Pharmacovigilance (RPPVs), managing safety database configurations, and authoring SOPs to maintain high standards of patient safety.

Location: Must be based in Sao Paulo, Brazil. This role offers flexible work arrangements including remote, hybrid, or on-site options.

Компания

hirify.global is a global biotechnology company dedicated to scientific innovation and patient safety.

Что делать

• Ensure GPS procedures comply with global PV regulations and standards.
• Oversee local Responsible Persons for Pharmacovigilance (RPPVs) and key vendors.
• Review and assess global PV regulatory intelligence and agreements.
• Collaborate cross-functionally to plan and verify safety database configuration compliance.
• Author and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Represent the company regarding patient safety matters and conduct safety issue presentations.

Требования

• University degree in life sciences or allied health fields required.
• Significant years of direct pharmacovigilance experience.
• Strong knowledge of Brazil & LATAM pharmacovigilance regulations and compliance.
• Fluent in English and Brazilian Portuguese required.
• Ability to work autonomously and effectively in a matrix environment.
• Proficiency in Microsoft Office applications.

Хорошо, если есть

• Proficiency in Spanish.

Культура и преимущества

• Commitment to equal employment opportunity and non-discrimination.
• Flexible work environment with remote, hybrid, and on-site options.
• Global collaborative team environment.
• Focus on scientific innovation and patient-centric outcomes.