Pharmacovigilance Analyst

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

📋 Description

• Oversee the local pharmacovigilance system to ensure adherence to national laws and regulations.

• Conduct searches of local literature.

• Manage local individual case safety reports (ICSRs).

• Execute pharmacovigilance intelligence screening.

• Maintain the local Pharmacovigilance System Master File (PSMF).

• Establish local Organized Data Collection.

• Manage local Pharmacovigilance Agreements (PVAs).

• Implement additional Risk Minimization Measures.

• Review materials pertinent to local post-authorization safety.

• Participate in audits and inspections related to pharmacovigilance.

• Attend regular project meetings.

• Provide monthly reports on the status of the local pharmacovigilance system.

• Ensure pharmacovigilance training for affiliate employees, service providers, and third parties.

• Collaborate with the client's global pharmacovigilance system as well as related global and local departments and functions.

• Issue, review, and maintain pharmacovigilance procedures, including Standard Operating Procedures and Working Practices, relevant to local tasks and client procedures.

⛳️ Requirements

• A university degree in Life Science.

• A minimum of 3 years of experience in pharmacovigilance.

• Expertise and understanding of relevant legislative and non-legislative pharmacovigilance guidelines.

• Capability to train and support junior or new colleagues in daily tasks.

• Ability to lead small projects with a clearly defined scope.

• Skill in managing relationships with internal and external clients at both operational and client team lead levels.

• Strong written and verbal communication skills.

• Ability to articulate issues and propose solutions.

• Business-fluent in English.

• Proficiency in Spanish (preferred).

• A Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience is required.

• Over 3 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field is required.

• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and training.

• Flexible working hours and a supportive work environment.

• Health and wellness programs.

• Collaborative team culture.