About the Role

Our client, a globally recognized pharmaceutical company, is seeking a meticulous and experienced Farmacéutico de Farmacovigilancia y Asuntos Regulatorios to join their team in Naucalpan, State of Mexico . This vital role ensures the safety and compliance of pharmaceutical products by monitoring adverse events and managing regulatory submissions. The successful candidate will be responsible for collecting, evaluating, and reporting adverse event data, as well as contributing to the preparation and maintenance of regulatory dossiers. This position requires a deep understanding of pharmacovigilance principles, regulatory affairs, and a commitment to patient safety. You will be instrumental in safeguarding public health by ensuring our products are used safely and effectively.

Key Responsibilities

- Monitor, collect, assess, and document adverse event reports from various sources.
- Ensure timely and accurate reporting of safety information to regulatory authorities.
- Conduct signal detection and risk assessment activities for assigned products.
- Prepare periodic safety update reports (PSURs) and other regulatory safety documents.
- Collaborate with internal departments (e.g., Medical Affairs, Clinical Development, Quality Assurance) and external stakeholders on safety matters.
- Contribute to the preparation and submission of marketing authorization applications and variations.
- Ensure compliance with national and international pharmacovigilance regulations and guidelines.
- Maintain safety databases and ensure data quality and integrity.




- Support regulatory inspections and audits related to pharmacovigilance and regulatory affairs.
- Provide training on pharmacovigilance requirements to relevant personnel.

Requirements

- Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy degree from an accredited institution.
- Valid pharmacy license in Mexico.
- Minimum of 3 years of experience in pharmacovigilance and/or regulatory affairs within the pharmaceutical industry.
- Strong knowledge of pharmacovigilance principles, adverse event reporting, and safety database management.
- Familiarity with relevant Mexican regulations (COFEPRIS) and international guidelines (ICH, CIOMS).
- Experience with regulatory submissions (e.g., MAAs, variations) is a plus.
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to clearly articulate complex information.
- Detail-oriented with a high degree of accuracy and organizational skills.
- Ability to work independently and manage multiple tasks effectively in a deadline-driven environment.
- Proficiency in relevant software, including safety databases and MS Office.

Benefits

- Our client offers a competitive salary, comprehensive benefits including medical, dental, and vision insurance, life insurance, and a retirement savings plan.
- This role is fully remote, offering significant flexibility.
- We invest in our employees' professional development through ongoing training and opportunities to attend industry conferences.
- Join our dedicated team in Naucalpan, State of Mexico , and contribute to ensuring the safety and accessibility of vital medicines.

📌 Farmacéutico de Farmacovigilancia y Asuntos Regulatorios (Naucalpan de Juárez)
🏢 Placements24
📍 Naucalpan de Juárez