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 general 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, Nuevo 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