Drug Safety Specialist
- This is a hybrid position. Candidates will be expected to dedicate 2-3 days per week in the office in Columbus, Ohio.
- 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.
- 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.
- 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.
- 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.
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