Senior Pharmacovigilance Analyst

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Evaluate and monitor safety data for marketed pharmaceuticals, ensuring adherence to both national and international pharmacovigilance regulations.

• Carry out safety assessments, trend analyses, and signal detection, while assisting in the preparation of product benefit-risk evaluations.

• Aid in the development, review, and implementation of procedures, work instructions, and workflows pertaining to the Pharmacovigilance System.

• Engage in strategic projects linked to new product development by contributing safety assessments and defining pharmacovigilance processes.

• Collaborate with external partners and associated companies to ensure technical alignment, facilitate information exchange, and maintain compliance with pharmacovigilance agreements.

• Contribute to benefit-risk evaluations, safety analyses, and signal detection initiatives.

• Assist with audits, regulatory inspections, and due diligence processes relevant to the field.

• Participate in structuring and continuously enhancing pharmacovigilance processes, promoting quality, traceability, and data reliability.

• Oversee timelines, deliverables, and requests related to projects under your jurisdiction.

⛳️ Requirements

• Education: Bachelor’s degree in Pharmacy or a related Health Sciences discipline.

• Experience: Proven experience in assessing and managing safety cases along with drug safety monitoring activities.

• Experience in project management, implementation, or process enhancement.

• Experience collaborating with multidisciplinary teams and external partners.

• Knowledge of national and international regulations pertinent to Good Pharmacovigilance Practices (RDC 406/2020, GVP, ICH, and other relevant standards).

• Advanced proficiency in English – conversational level.

🏝️ Benefits

• Health insurance

• Meal allowance

• Transportation allowance

• Life insurance