Top 11 Regulatory documentation specialist ii Jobs in Columbus

Pharmacovigilance Specialist I, II, III
Gifthealth Inc —Columbus, OH
- $68,000 - $92,000 a year
- Full-time
- Hybrid work
- Nursing
- Mid-level
- Bachelor's degree
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Drug Safety Specialist I, II, III
Gifthealth Inc —Columbus, OH
- $23 - $31 an hour
- Full-time
- Hybrid work
- Nursing
- Mid-level
- High school diploma or GED
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Intake Specialist II, III
Gifthealth Inc —Columbus, OH
- $20.14 - $27.15 an hour
- Full-time
- Hybrid work
- HIPAA
- Mid-level
- High school diploma or GED
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Treasury Mgmt Service Specialist II
Huntington Bank —Columbus, OH
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Research
Environmental Rep II
EOG Resources —New Albany, OH
- Full-time
- 5 years
- Engineering
- Mid-level
Staff Surveyor II
Verdantas —Dublin, OH
- $85,000 a year
- Full-time
- Mid-level
- Office
- Ability to lift 50 pounds
- Paid parental leave
- AD&D insurance
Team Lead Firewall Admin (Checkpoint)
ITinfra —Columbus, OH
- Email
- 7 years
- Azure
- Continuous improvement
- Health insurance
- 401(k)
Case Manager - Whitehall
BASECAMP RECOVERY LLC —Columbus, OH
- Full-time
- LPC
- Mid-level
- 3 years
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Product Engineer II
Mettler Toledo —Columbus, OH
- Bachelor of Science
- Mid-level
- Analysis skills
- Disability insurance
- Health insurance
Storage Architect
AGE Solutions —Columbus, OH
- From $105,000 a year
- Full-time
- Mid-level
- Office
- Team management
- Paid training
- Paid parental leave
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Drug Safety Specialist I, II, III
Gifthealth Inc —Columbus, OH
Bachelor’s degree in life sciences, healthcare, nursing, pharmacy, or related field (Preferred). Experience with pharmacy systems, ticketing platforms, or…
$23 - $31 an hour
Quick Apply
Pharmacovigilance Specialist I, II, III
Gifthealth Inc —Columbus, OH
Bachelor’s degree in healthcare management, pharmacy, nursing, life sciences, or related field (required). Communicates appropriately with patients and internal…
$68,000 - $92,000 a year
Quick Apply

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Pharmacovigilance Specialist I, II, III
Gifthealth Inc —Columbus, OH
Bachelor’s degree in healthcare management, pharmacy, nursing, life sciences, or related field (required). Communicates appropriately with patients and internal…
$68,000 - $92,000 a year
Quick Apply
Drug Safety Specialist I, II, III
Gifthealth Inc —Columbus, OH
Bachelor’s degree in life sciences, healthcare, nursing, pharmacy, or related field (Preferred). Experience with pharmacy systems, ticketing platforms, or…
$23 - $31 an hour
Quick Apply

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Pharmacovigilance Specialist I, II, III

Gifthealth Inc -
Columbus, OH

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Job Details

Full-time
$68,000 - $92,000 a year

Qualifications

Investigations regulatory compliance
Adverse event reporting
Caseload management
Good documentation practices (GDP)
Internal investigations
Bachelor's degree
Adverse drug reaction monitoring
Patient interaction
Patient safety healthcare investigations

Full Job 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

We are seeking a Pharmacovigilance Specialist I. Reporting to the Adverse Events & Product Complaints (AEPC) Lead, the Pharmacovigilance Specialist I is responsible for the intake, investigation, documentation, and reporting of all Adverse Events (AEs) and Product Complaints (PCs) in accordance with FDA and manufacturer requirements. This role ensures all AEPC cases are fully investigated, accurately documented, and submitted within the required 24-hour reporting timeline. The specialist responds to patient-reported safety concerns, gathers required information, and maintains complete audit-ready records in compliance with Good Documentation Practices (GDP) and regulatory standards.

This position plays a key role in supporting the AEPC team, ensuring alignment with organizational goals, operational excellence, and compliance standards.

Key Responsibilities

Completes intake, document, and submit all Adverse Events and Product Complaints within 24-hour FDA and manufacturer SLA requirements
Investigates patient-reported events by gathering complete and accurate information in accordance with regulatory guidelines
Maintains AEPC documentation in QMS systems ensuring accuracy, traceability, and audit readiness
Validates AEPC case completeness, including timelines, product details, and patient outcomes
Communicates appropriately with patients and internal teams regarding AEPC investigations and next steps
Supports AEPC trend analysis and reporting as directed by AEPC Lead
Supports internal and external audits related to AEPC reporting

Qualifications

Education:
Bachelor’s degree in healthcare management, pharmacy, nursing, life sciences, or related field (required)
Pharmacovigilance, drug safety, or regulatory compliance training (Preferred)
Licensure/Certification: None
Minimum Experience Required for Pharmacovigilance Specialist I (requirements vary based on leveling):
Minimum 1-3 years of experience in adverse event reporting, quality, compliance, or regulated healthcare operations (Required)
Experience working with FDA AEPC submissions or manufacturer safety reporting requirements (Preferred)
Experience with QMS systems and safety databases (Preferred)
Knowledge, Skills & Abilities:
Working knowledge of call center or intake workflows supporting AE/PC review
Knowledge of FDA AE/PC reporting requirements; 21 CFR Part 314.80 and FDA post-marketing safety reporting standards; Good Documentation Practices (GDP) and ALCOA principles; AEPC investigation and case documentation standards (Required)
Knowledge of manufacturer-specific AEPC reporting portals; pharmacovigilance workflows in a pharmacy or healthcare environment (Preferred)
Data tracking and reporting skills (Preferred)
Ability to manage multiple AEPC cases simultaneously while meeting strict deadlines (Required)
Ability to conduct patient-facing investigations with professionalism and empathy (Required)
Ability to Identify potential trends or patterns in AEPC data (Preferred)

Work Environment

Location: Hybrid/On-site
Schedule: Monday through Friday
May require availability during peak periods or flexibility for escalations.
Regular meetings with internal Compliance, Quality, Call Center and Patient Support teams. This role will also interact with pharmaceutical manufacturers as directed by leadership and regulatory bodies as determined by business needs.

Key Essential Functions

Must be able to stand for at least 4 hours at a time while working
Must be able to lift up to 25 pounds with or without assistance.
Must perform repetitive motions for an entire shift: bending, reaching, lifting, scanning.
Must be able to work onsite for all shifts.

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.

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Refine Your Search

regulatory documentation specialist ii jobs in columbus

Pharmacovigilance Specialist I, II, III

Drug Safety Specialist I, II, III

Intake Specialist II, III

Treasury Mgmt Service Specialist II

Environmental Rep II

Staff Surveyor II

Team Lead Firewall Admin (Checkpoint)

Case Manager - Whitehall

Product Engineer II

Storage Architect

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Position Summary

Key Responsibilities

Qualifications

Key Essential Functions

Employment Classification

Equal Employment Opportunity (EEO) Statement

Disclaimer

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