Job Title: Local Pharmacovigilance Officer
Location: Argentina (Remote)
Department: Drug Safety Services
Employment Type: Contractual, As-Needed Basis
Work Availability: Must be available during local business hours
Role Overview
The Local Pharmacovigilance Officer collaborates with global pharmacovigilance teams and cross-functional stakeholders to ensure compliance with regional and national regulatory requirements for medicinal products. The role primarily involves translation of safety and non-safety information, pharmacovigilance activity support, regulatory submissions, and management of local safety reporting processes. The position plays a critical role in maintaining compliance with international drug safety standards and ensuring accurate reporting of adverse events.
Key Responsibilities
Translate and perform quality review of incoming safety and non-safety information using manual or automated processes.
Ensure accurate, complete, and timely translation of safety-related data.
Maintain compliance with international and local regulatory requirements, including GDPR and applicable data protection laws.
Access and review suspected adverse reaction reports and support monitoring of regulatory submissions.
Conduct non-English follow-ups via phone, email, or other communication channels to collect safety information.
Assist in preparation of local submission packages, including health authority forms in local languages.
Monitor and remain updated on national pharmacovigilance and regulatory requirements.
Handle medical information inquiries from patients and healthcare professionals.
Ensure adherence to global pharmacovigilance regulations and guidelines, including CIOMS, EMA, FDA, and ICH standards.
Follow Sitero’s standard operating procedures (SOPs) and quality standards.
Support case report distribution and National Competent Authority (NCA) submissions.
Promote collaboration, teamwork, and continuous process improvement within pharmacovigilance operations.
Education and Experience Required
Fluency in both 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, but relevant experience required).
Minimum 2 years of relevant experience in medical, clinical, scientific, or pharmaceutical domains is preferred.
Preferred Skills and Qualifications
Working knowledge of Good Pharmacovigilance Practices and global drug safety regulations, including US and EU requirements.
Experience in safety data review, analysis, and case processing from multiple sources.
Familiarity with global clinical and post-marketing safety reporting requirements.
Experience with MedDRA, 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.
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. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
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