Drug Safety Specialist Job at giftHEALTH Inc, Columbus, OH

OHE2cU93Rmt0Y3RMb0dMalZ2K2pNa3doaEE9PQ==
  • giftHEALTH Inc
  • Columbus, OH

Job Description

Job Description

Job 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. 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.

Requirements:

Job Tags

Full time, Work at office, 2 days per week, 3 days per week,

Similar Jobs

Kohl's

Assistant Designer Job at Kohl's

 ...About the Role As an Assistant Designer, you will support Design leaders in creating an assortment that aligns with brand positioning and target customers. What Youll Do Build, create and maintain tech packs, trim sheets and design packages Ensure accurate... 

ACL Digital

Packaging Engineer Job at ACL Digital

 ...Job Description Job Title: Packaging Engineer Location: Thousand Oaks, CA Duration: 12+ Months Description This position reports into the Packaging Engineering group under Combination Product Operations (CPO) and is located in Thousand Oaks, CA. The... 

Crash Champions

Auto Body Technician Job at Crash Champions

 ...meetings. \n \n Files, grinds, and sands repaired surfaces, using power tools and hand tools. \n \n Directs the work of an apprentice in the performance of tasks when needed, i.e., unusual problems or questions and explains procedures to assistant. \n \n\n \n... 

Cayuga County New York

Assistant County Attorney Job at Cayuga County New York

 ...the position has been filled HOW TO APPLY: Go to: mycivilservice.cayugacounty.us/jobopps and click on the APPLY button across from the title of Assistant County Attorney - Vacancy under Current Vacancies. MINIMUM QUALIFICATIONS: Graduation from... 

MRG Exams

Clinical Psychologist - Madison AL Job at MRG Exams

 ...Requirements:~ Has a Ph.D. or Psy.D and has graduated from an APA Accredited program/school.~ Holds an active & unrestricted Psychology license.~ Comfortable using technology to review records and complete documentation. Compensation & Benefits:~...