Pharmacovigilance Manager

Description

Position Summary: Pharmacovigilance Manager responsible for ensuring compliance with the pharmacovigilance system and managing the safety of pharmaceutical products. Key Highlights: 1. Lead the preparation for and response to regulatory audits and inspections. 2. Ensure the implementation and compliance of the Pharmacovigilance System. 3. Coordinate local and regional pharmacovigilance activities. Pharmacovigilance Manager – Argentina A leading multinational pharmaceutical company is seeking a **Pharmacovigilance Manager** to work onsite in Argentina. Requirements * Graduate professional in **Pharmacy**. * Prior experience in pharmacovigilance within the pharmaceutical industry. * Knowledge and experience in **adverse event reporting via E\-Reporting systems**, follow-up management, and use of **MedDRA** and **WHODrug** dictionaries. * Experience in preparing, adapting, and/or submitting **Periodic Safety Update Reports (PSUR/PBRER)**. * Knowledge and experience in managing and submitting **Risk Management Plans (RMP)** and monitoring risk minimization measures. * Experience in **regulatory intelligence** and reviewing scientific literature related to drug safety. * Training and knowledge of **Good Pharmacovigilance Practices (GVP)**. * Experience interacting with regulatory authorities, audits, and inspections. * Advanced level of **English** (mandatory). Key Responsibilities * Ensure the implementation, maintenance, and compliance of the Company’s Pharmacovigilance System in Argentina, in accordance with applicable regulations. * Serve as the official liaison with the local regulatory authority. * Lead the preparation for and response to regulatory and licensor audits and inspections. * Guarantee compliance with regulatory requirements related to product safety. * Coordinate local pharmacovigilance activities and provide support to pharmacovigilance operations across Latin America. * Manage adverse events, periodic safety reports, risk management plans, and regulatory surveillance activities. Workplace: Onsite employment