Drug Safety Specialist at Gifthealth

Columbus, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Mar, 26

Salary

0.0

Posted On

17 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Clinical Trial Experience, Regulatory Compliance, Adverse Events Documentation, Product Complaints Management, Safety Data Monitoring, Risk Assessment, Patient Engagement, Collaboration, Attention to Detail, HIPAA Compliance, Good Clinical Practices, FDA Regulations, Documentation, Communication, Problem Solving

Industry

technology;Information and Internet

Description

Description About Us At Gifthealth, we're revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We're a dynamic, innovative, and customer-centric company dedicated to making a positive impact on people's lives. Position Summary The Drug Safety Specialist will play a critical role in ensuring patient safety and regulatory compliance by triaging, documenting, and escalating Adverse Events (AEs) and Product Complaints (PCs) related to pharmaceutical therapies. ** This is a hybrid position, and candidates will be expected to dedicate 2-3 days per week in the office in Columbus, Ohio. Key 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 oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data. Support investigations and evaluations of adverse events, including reviewing pharmacy records and collaborating with cross-functional teams. Stay up-to-date with current drug safety regulations and guidelines. Engage with patients regarding adverse event and complaint details, then accurately complete all 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 all times. Qualifications 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 related activities are required. Proactive, hardworking, and always willing to take on new tasks. Work Environment Location: Hybrid Columbus OH Schedule: Full-time May require additional availability or flexibility for escalations. Regular meetings with teams, departments, or leadership to ensure alignment. Key Essential Functions Must be able to sit and/or work at a computer for extended periods of time. Must be able to use standard office equipment, including a computer, keyboard, mouse, and telephone. Must be able to perform repetitive motions throughout the workday, including typing, reading, and reviewing documentation. Must be able to communicate effectively with internal and external stakeholders in person, via video conference, and in writing. Must be able to work during standard business hours. Employment Classification Status: Full-time FLSA: Exempt Equal Employment Opportunity (EEO) Statement Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status. We celebrate diversity and are committed to creating an inclusive environment for all employees. If you do not meet every requirement but still feel you would be a great fit for this role, we encourage you to apply! Disclaimer This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel. Gifthealth reserves the right to modify job duties or descriptions at any time.

Responsibilities

The Drug Safety Specialist will monitor and evaluate safety data, manage product safety data, and ensure compliance with FDA regulations. They will also engage with patients regarding adverse events and complaints, ensuring accurate documentation and risk assessment.