Job Description
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 - 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.
- Applies clinical and regulatory knowledge to assess risk and determine appropriate escalation paths for adverse event reports.
- Plays a key role in ensuring organizational compliance with FDA pharmacovigilance regulations and preventing regulatory risk.
- Independently evaluates the severity of patient-reported issues in alignment with internal SOPs and federal guidelines
Qualifications - 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.
Our Offer to Ensure You Choose Gifthealth
- 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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