About the Role

Our client, a prominent pharmaceutical company dedicated to advancing healthcare through innovative solutions, seeks a highly skilled and motivated Especialista en Farmacovigilancia Senior to join their dynamic team in Monterrey, Nuevo León. This is an exceptional opportunity to contribute to patient safety by ensuring the rigorous monitoring and reporting of adverse drug reactions. The role demands a deep understanding of regulatory requirements and a proactive approach to risk management. You will play a pivotal role in upholding the highest standards of product safety and compliance within a collaborative and forward-thinking environment. The ideal candidate will possess a strong analytical mindset, excellent communication skills, and a commitment to ethical pharmaceutical practices. This position offers the chance to work on cutting-edge therapies and make a tangible impact on public health.

Key Responsibilities

- Monitor, collect, and evaluate adverse event reports for assigned products.
- Ensure compliance with national and international pharmacovigilance regulations and guidelines.
- Prepare and submit regulatory reports, including Periodic Safety Update Reports (PSURs) and other safety-related documents.
- Collaborate with cross-functional teams, including Medical Affairs, Regulatory Affairs, and Clinical Development, to ensure consistent safety messaging.
- Conduct signal detection activities to identify potential new safety concerns.
- Contribute to the development and implementation of pharmacovigilance processes and SOPs.
- Provide training and guidance to internal and external stakeholders on pharmacovigilance matters.




- Manage safety database entries and ensure data accuracy and completeness.
- Participate in internal and external audits and inspections related to pharmacovigilance.
- Stay updated on the latest scientific literature and regulatory changes impacting pharmacovigilance.

Requirements
- Bachelor's or Master's degree in Pharmacy, Biology, Chemistry, Medicine, or a related life science field.
- Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, COFEPRIS).
- Proven experience in signal detection, risk assessment, and reporting.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong understanding of medical terminology and drug classifications.
- Proficiency in safety databases (e.g., Argus, ARISg) and common reporting tools.
- Excellent written and verbal communication skills in Spanish.
- Fluency in English is highly desirable.
- Ability to work effectively both independently and as part of a team in a Hybrid work setting in Monterrey, Actual León.

Benefits

Our client offers a competitive salary package, comprehensive health and life insurance, retirement savings plan, generous paid time off, opportunities for professional development and continuous learning, and a stimulating work environment that fosters innovation and collaboration. Employees also benefit from access to state-of-the-art facilities and cutting-edge research projects. We are committed to work-life balance and offer programs that support employee well-being. Join us and be part of a team that values integrity, excellence, and making a difference in people's lives.

📌 Especialista En Farmacovigilancia Senior (Monterrey)
🏢 Placements24
📍 Monterrey