Local Pharmacovigilance Officer (Contract) – Drug Safety Services | Remote | Mexico City, Mexico
Sitero, a growing leader in clinical services and technology-enabled software solutions for the global life sciences industry, is hiring a Local Pharmacovigilance Officer to support its Drug Safety operations. With deep expertise across multiple therapeutic areas, Sitero provides innovative and compliance-driven solutions from early-phase development through Phase III clinical trials. The organization focuses on patient safety, regulatory excellence, ethical standards, and advanced technology to support stakeholders across the clinical research ecosystem.
This remote contractual opportunity is suitable for professionals with experience in pharmacovigilance, drug safety operations, medical information management, and regulatory compliance.
Job Title: Local Pharmacovigilance Officer
Location: Mexico (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 fields.
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 involves translation of safety and non-safety information, support of pharmacovigilance activities, regulatory submission assistance, and management of local safety reporting processes. The position ensures compliance with global drug safety standards and contributes to accurate adverse event reporting and regulatory oversight.
Key Responsibilities
Perform translation and quality review of incoming safety and non-safety information using manual or automated methods.
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 assist in monitoring regulatory submissions.
Conduct non-English follow-ups via phone, email, or other communication channels to collect safety information.
Support preparation of local submission packages, including health authority forms in local languages.
Stay updated on national pharmacovigilance and regulatory 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 process improvement.
Education and Experience Requirements
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; relevant experience required).
Minimum 2 years of relevant experience in medical, clinical, scientific, pharmaceutical, or pharmacovigilance roles preferred.
Preferred Skills and Qualifications
Strong knowledge of Good Pharmacovigilance Practices and global drug safety regulations, including US and EU requirements.
Experience in safety data review, case processing, and analysis of safety information from multiple sources.
Familiarity with global clinical and post-marketing safety reporting requirements and regulatory 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.
Problem-solving capabilities 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 regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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