Pharmacovigilance Specialist – Biotech

Acerca de la Empresa

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. We are one of the world’s largest biotech companies, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Our commitment to innovation and patient care drives us to deliver breakthrough medicines and diagnostic solutions. We believe that diverse perspectives and backgrounds are essential for innovation and are committed to fostering an inclusive environment for all employees.

Descripción del Trabajo

We are seeking a dedicated and detail-oriented Pharmacovigilance Specialist to join our team in Santa Cruz de la Sierra, Bolivia. In this crucial role, you will be responsible for the collection, processing, and reporting of adverse event information, ensuring compliance with global and local regulatory requirements. You will play a vital part in safeguarding patient safety by meticulously monitoring and evaluating drug safety data for our innovative biotech products. This position requires a strong understanding of pharmacovigilance principles, excellent analytical skills, and a commitment to maintaining the highest standards of data integrity.

Responsabilidades Clave

• Process and manage individual case safety reports (ICSRs) from various sources, including spontaneous reports, literature, and clinical trials.
• Perform causality assessment, seriousness assessment, and expectedness assessment for adverse events.
• Ensure timely and accurate data entry into the safety database, adhering to standard operating procedures (SOPs) and regulatory guidelines.
• Generate and submit expedited and periodic safety reports to local and international health authorities.
• Participate in signal detection and risk management activities, contributing to the development of risk management plans.
• Respond to safety-related queries from internal stakeholders, healthcare professionals, and regulatory agencies.
• Maintain up-to-date knowledge of relevant pharmacovigilance regulations (e.g., ICH, local regulations).
• Assist in the preparation for and participation in pharmacovigilance audits and inspections.

Habilidades Requeridas

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance within the pharmaceutical or biotechnology industry.
• Proficiency in pharmacovigilance databases and safety reporting tools.
• Strong understanding of global and local pharmacovigilance regulations (e.g., ICH guidelines, local Bolivian regulations).
• Excellent written and verbal communication skills in English and Spanish.
• High level of attention to detail and accuracy.
• Ability to work independently and collaboratively in a fast-paced environment.

Cualificaciones Preferidas

• Master’s degree or PharmD.
• Experience with ARGUS safety database.
• Knowledge of clinical trial processes and data management.
• Certification in Pharmacovigilance or Drug Safety.

Ventajas y Beneficios

• Competitive salary and performance bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Generous paid time off and holidays.
• Opportunities for professional development and continuous learning.
• Employee wellness programs and initiatives.
• Dynamic and inclusive work environment.

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