Pharmacovigilance Scientist - Drug Safety
About the Role
Our client, a prominent pharmaceutical entity, is seeking a diligent and experienced Pharmacovigilance Scientist to bolster their drug safety team in Columbus, Ohio . This crucial role involves the meticulous monitoring of drug safety profiles, ensuring the safety of patients receiving their medications. You will be responsible for the collection, assessment, and reporting of adverse event data, contributing to the overall safety strategy of their pharmaceutical products. This hybrid position allows for a blend of in-office collaboration and remote flexibility, enabling you to contribute effectively from the Columbus, Ohio area. We are dedicated to maintaining the highest standards of patient safety and are looking for a skilled professional to uphold this commitment within the pharmaceutical landscape. This is an excellent opportunity for career growth in a vital area of drug development.
Key Responsibilities
Collect, process, and evaluate adverse event (AE) and adverse event of special interest (AESI) reports from various sources. Ensure accurate and timely entry of safety data into the pharmacovigilance database. Perform medical assessment of AE reports, including causality and severity assessments. Prepare and submit regulatory safety reports (e.g., DSURs, PADERs) to health authorities. Collaborate with clinical operations, medical affairs, and regulatory departments on safety-related matters. Contribute to the development and review of aggregate safety reports and signal detection activities. Participate in safety review meetings and provide expert input on drug safety issues. Support the development and implementation of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS). Maintain a thorough understanding of global pharmacovigilance regulations and guidelines. Assist in training site personnel and internal staff on pharmacovigilance procedures.
Requirements
Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field. A Master's or Pharm.D. is preferred. Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry. Strong understanding of pharmacovigilance principles, processes, and regulatory requirements (e.g., FDA, EMA). Experience with safety databases (e.g., Argus, ARISg) and adverse event reporting. Excellent medical assessment skills and ability to interpret clinical data. Strong written and verbal communication skills, with the ability to present complex safety information clearly. Proficiency in Microsoft Office Suite. Ability to work independently, manage time effectively, and meet strict deadlines. Detail-oriented with a high degree of accuracy. Ability to work effectively in a hybrid environment, balancing remote work with necessary in-office collaboration in the Columbus, Ohio vicinity.
Benefits
Competitive salary reflective of experience and qualifications. Comprehensive health, dental, and vision insurance. 401(k) retirement plan with company match. Generous paid time off and holidays. Opportunities for professional development and continuing education in pharmacovigilance. Hybrid work arrangement offering work-life balance. A role within a respected pharmaceutical company contributing to patient well-being. Access to internal training and mentorship programs. Potential for annual bonuses and performance incentives.