Drug Safety Specialist
Gifthealth
Date: 11 hours ago
City: Columbus, Ohio
Contract type: Full time
About Gifthealth
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.
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.
Key Responsibilities
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.
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.
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.
- A minimum of two to four years of experience in a clinical, pharmacy, or pharmacovigilance environment is required.
- Knowledge of Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and/or Good Clinical Practices (GCP).
- Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
- 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.
- Competitive compensation based on education, experience and performance
- Comprehensive healthcare benefits offered by Gifthealth
- Opportunity to advance a non-traditional pharmacy with a technology focus
- Freedom to collaborate with a team of healthcare experts that share in the passion of improving medication accessibility and affordability
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