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

📋 Description

• Conduct local literature reviews.

• Oversee local individual case safety reports (ICSRs).

• Carry out pharmacovigilance intelligence assessments.

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

• Establish local Organized Data Collection.

• Manage local pharmacovigilance agreements (PVAs).

• Implement supplementary risk minimization strategies.

• Review documents related to local post-authorization safety.

• Engage in pharmacovigilance-related audits and inspections.

• Attend regular project meetings.

• Provide monthly pharmacovigilance updates on the status of the local PV system in the respective country or countries.

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

• Collaborate with the client's global PV system alongside relevant global and local departments and functions.

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

⛳️ Requirements

• A Bachelor's degree in life sciences, pharmacy, chemistry, biology, public health, biomedical sciences, healthcare administration, or a related discipline, or equivalent experience is required.

• A minimum of 2 years of experience in scientific consulting, life sciences consulting, healthcare consulting, clinical operations, medical affairs support, research analysis, or a related field is required.

• Project Management Professional (PMP) or an equivalent certification is preferred.

• Certified Associate in Project Management (CAPM) or an equivalent certification is preferred.