Pharmacovigilance Responsible | São Paulo

Pharmacovigilance Responsible | São Paulo

A pharmaceutical company is looking for a Pharmacovigilance Responsible to join its team in São Paulo, Brazil.

We are seeking a professional with solid experience in pharmacovigilance, regulatory requirements, and drug safety processes.

Key Responsibilities:

• Management and reporting of adverse events to ANVISA, including case follow-up and management.
• Management of MedDRA and WHODrug dictionaries.
• Preparation, submission, and adaptation of Periodic Safety Update Reports (PSURs).
• Preparation, submission, and management of Risk Management Plans (RMPs), including follow-up of risk minimization measures.
• Conducting Regulatory Intelligence activities and scientific literature reviews related to pharmacovigilance and drug safety.
• Management of investigations, root cause analysis, deviation management, and development and follow-up of CAPAs.
• Ensuring compliance with Good Pharmacovigilance Practices (GVP) and applicable regulatory requirements.
• Supporting the continuous improvement of pharmacovigilance processes and procedures.

Requirements:

• Bachelor’s degree in a Health Sciences-related field.
• Previous experience in Pharmacovigilance, preferably within the pharmaceutical industry.
• Experience with regulatory processes and interaction with ANVISA.
• Knowledge of MedDRA and WHODrug dictionaries.
• Training or experience in Good Pharmacovigilance Practices (GVP).
• Experience in deviation investigations, root cause analysis, and CAPA management.
• Advanced English, both written and conversational.
• Strong analytical, organizational, communication, and teamwork skills.

Location: São Paulo, Brazil

Work Model: 100% On-site