Job Title: Local Pharmacovigilance Officer
Location: Uruguay (Remote)
Department: Drug Safety Services
Employment Type: Contractual, As-Needed Basis
Work Schedule: Availability required during local business hours
Experience Required: Minimum 2 years of relevant experience preferred in pharmacovigilance, clinical research, medical, scientific, or pharmaceutical roles.
Role Overview
The Local Pharmacovigilance Officer collaborates with global pharmacovigilance teams and cross-functional stakeholders to ensure compliance with applicable regional and national regulatory requirements for medicinal products. The role primarily involves translation of safety and non-safety information, support of pharmacovigilance activities, regulatory submission assistance, and management of local safety reporting processes. The position plays a critical role in maintaining global drug safety standards and ensuring accurate adverse event reporting.
Key Responsibilities
Perform translation and quality review of incoming safety and non-safety information using manual or automated processes.
Ensure accurate, complete, and timely translation of safety-related information.
Maintain compliance with international and local regulatory requirements, including GDPR and applicable data protection laws.
Access and review suspected adverse reaction reports and assist in monitoring regulatory submissions.
Conduct non-English follow-ups via phone, email, or other communication channels to obtain safety information.
Support preparation of submission packages, including local health authority forms in local languages.
Stay updated on national pharmacovigilance and regulatory affairs requirements.
Handle medical information inquiries from patients and healthcare professionals.
Ensure compliance with global pharmacovigilance regulations and guidelines, including CIOMS, EMA, FDA, and ICH standards.
Follow Sitero standard operating procedures (SOPs) and quality standards.
Support case report distribution and National Competent Authority (NCA) submissions.
Promote collaboration, teamwork, and continuous improvement within pharmacovigilance operations.
Education and Experience Requirements
Fluency in source and target languages, with native or near-native proficiency in the target language.
Strong written communication and translation skills.
Training in pharmacovigilance terminology and processes.
Documented pharmacovigilance training, including SOP training and Good Pharmacovigilance Practice (GVP) awareness.
Understanding of medical terminology (medical degree not mandatory; relevant experience required).
Minimum 2 years of relevant experience in medical, clinical, scientific, pharmaceutical, or pharmacovigilance environments preferred.
Preferred Skills and Qualifications
Strong knowledge of Good Pharmacovigilance Practices and global drug safety regulations, including US and EU regulatory requirements.
Experience in safety data review, case processing, and analysis of safety information from multiple sources.
Familiarity with global clinical and post-marketing safety regulations, guidance documents, and reporting processes.
Experience with MedDRA and XEVMPD coding and safety database systems.
Ability to contribute to development and implementation of SOPs, work instructions, and safety guidelines.
Strong organizational, analytical, presentation, and communication skills.
Demonstrated problem-solving ability with a comprehensive understanding of pharmacovigilance operations.
Equal Opportunity Statement
Sitero is an equal opportunity employer and welcomes applications from all qualified candidates. All employment decisions are made without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other status protected by applicable law.
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