About the Role
Our client, a globally recognized pharmaceutical company, is seeking a highly skilled and experienced Senior Pharmacovigilance Specialist to join their dynamic team. This fully remote position offers the opportunity to contribute significantly to patient safety by monitoring and reporting adverse events associated with pharmaceutical products. You will be instrumental in ensuring compliance with global regulatory requirements for pharmacovigilance. The role involves in-depth case processing, signal detection, and risk management activities. The ideal candidate will have a strong understanding of drug safety principles, regulatory landscapes, and a meticulous approach to data management. This is an exceptional chance to work from anywhere in the US with a company that prioritizes safety, innovation, and employee well-being.
Key Responsibilities Process, evaluate, and report adverse event cases in accordance with global regulatory requirements and company SOPs. Perform detailed case narrative writing and maintain accurate and complete case files. Conduct aggregate data review and contribute to the preparation of periodic safety update reports (PSURs/PBRERs). Identify potential safety signals through data analysis and contribute to signal detection activities. Collaborate with internal departments (e.g., Regulatory Affairs, Medical Affairs, Clinical Operations) and external stakeholders on safety-related matters. Assist in the development and maintenance of pharmacovigilance procedures and training materials. Participate in regulatory inspections and audits related to pharmacovigilance. Support risk management activities, including the development and implementation of risk management plans. Stay current with global pharmacovigilance regulations, guidelines, and best practices. Contribute to the continuous improvement of pharmacovigilance processes and systems. Requirements Bachelor's degree in a healthcare or life science field (e.g., Pharmacy, Nursing, Biology). A Master's degree or equivalent experience is preferred. Minimum of 5 years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical industry. Comprehensive knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS). Experience with adverse event case processing, including narrative writing and MedDRA coding. Familiarity with aggregate data analysis, signal detection, and risk management concepts. Proficiency in pharmacovigilance databases and safety reporting systems. Excellent written and verbal communication skills, with strong attention to detail. Ability to work independently, manage time effectively, and meet strict deadlines in a remote setting. Strong analytical and problem-solving skills. Benefits
Our client offers a highly competitive salary, annual bonus opportunities, and a robust benefits package. This includes comprehensive health, dental, and vision insurance, a 401(k) plan with a generous employer match, life insurance, short-term and long-term disability coverage, and paid time off. The company strongly invests in employee growth, offering professional development programs, training, and opportunities for advancement. As a fully remote role, it provides excellent work-life balance and flexibility.