Pharmacovigilance Chemist

Description

Position Summary: We are seeking a Senior Pharmacovigilance Chemist for Regulatory Affairs, responsible for developing and updating procedures, ensuring regulatory compliance, and generating safety reports. Key Highlights: 1. Integration into the Regulatory Affairs / Pharmacovigilance Department 2. Preparation of periodic safety reports and signal evaluation 3. Compliance with current regulations and development of procedures Farmacéutica Hispanoamericana is seeking a **Senior Pharmacovigilance Chemist** to join the Regulatory Affairs / Pharmacovigilance Department. **Requirements:** * Completed bachelor's degree in Pharmacy and Biochemistry (QFB), Food Engineering (IF), Industrial Chemistry (IQI), Biomedical Chemistry (IBQ), Biotechnology (IBT), or related field. * **1 to 2 years** of experience in pharmacovigilance. * Knowledge of: * NOM-220-SSA1-2016 and 2020. * NOM-240-SSA1-2012. * Guideline for the preparation of PBRER/IPP. * NOM-072-SSA1-2012. * Basic/intermediate English proficiency preferred. * Proficiency in Microsoft Office suite. **Main Responsibilities:** * Develop and update procedures according to departmental and company needs. * Carry out activities to ensure compliance with current regulations. * Prepare periodic safety reports, pharmacovigilance reports, risk management plans, and medical-scientific literature searches. * Evaluate safety signals. * Draft responses to pharmacovigilance-related regulatory observations. * Report activities to supervisors. **Competencies:** * Effective communication. * Proactivity. * Analytical thinking. * Teamwork. * Adherence to regulations. * Self-directed learning. **We Offer:** * Monthly salary: **$15,702 gross**. * Statutory benefits. * Enhanced benefits. * Grocery vouchers. * Savings fund. * Temporary contract for 3 months. * Work location: **Saavedra, CDMX**. * Working hours: **Monday to Saturday, 8:30 AM to 5:30 PM**. Salary: $7,569.96 per month Workplace: On-site employment