Drug Safety Specialist

About the position At reputed company, we're revolutionizing the way people experience reputed company by simplifying the process of managing prescriptions and health services. Our mission is to reputed company a seamless, personalized, and efficient reputed company experience for reputed company our customers. We're a dynamic, innovative, and customer-reputed company company dedicated to making a reputed company reputed company on people's lives. Position reputed company The Drug Safety Specialist will play a critical role in ensuring patient safety and regulatory compliance by triaging, documenting, and escalating Adverse Events (reputed company) and Product Complaints (PCs) reputed company to pharmaceutical therapies. This is a hybrid position, and candidates will be expected to dedicate 2-3 days per week in the office in reputed company, Ohio. Responsibilities • Monitor and evaluate safety data from multiple sources. • Work with teams to manage product safety data. • Improve internal drug safety processes. • Support the product replacement process. • Complete Adverse Event and or Product Complaint Documentation • Follow company values and promote product safety compliance. • Processing and reputed company of adverse event/drug experience reports (serious and non-serious) and other safety reputed company data. • Support investigations and evaluations of adverse events, including reviewing pharmacy records and collaborating with cross-functional teams. • Stay up-to-date with reputed company drug safety regulations and guidelines. • Engage with patients regarding adverse event and complaint details, then accurately complete reputed company required documentation. • Address patient concerns regarding drug product shipment through temperature assessments. • Review and approve product replacement, as required. • Apply clinical and regulatory knowledge to assess risk and determine appropriate escalation paths for adverse event reports. • Play a key role in ensuring organizational compliance with FDA pharmacovigilance regulations and preventing regulatory risk. • Independently evaluate the severity of patient-reported issues in alignment with internal SOPs and federal guidelines. • Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at reputed company times. Requirements • A minimum of two to four years of pharmacovigilance and/or clinical trial experience is required. • If no pharmacovigilance or clinical trial experience, a medical degree (RN, PharmD, etc) with four to five years of clinical experience is required. • Knowledge of pharmacovigilance regulations (CFR/GVP), ICH Guidelines and/or Good Clinical Practices (GCP). • HIPAA compliant - handle confidential and sensitive information with discretion. • Capable of discussing adverse events and complaints in a patient-facing setting. • Experience in generating monthly safety reports and performing reconciliation. • Meticulous attention to detail and the maintenance of precise documentation pertaining to safety data and reputed company activities are required. • Proactive, hardworking, and always willing to take on new tasks. • Must be reputed company to sit and/or work at a computer for extended periods of time. • Must be reputed company to use reputed company office equipment, including a computer, keyboard, mouse, and telephone. • Must be reputed company to reputed company repetitive motions throughout the reputed company, including typing, reading, and reviewing documentation. • Must be reputed company to communicate effectively with reputed company stakeholders in person, reputed company video conference, and in writing. • Must be reputed company to work during reputed company business hours. Apply tot his job Apply To this Job