Pharmacovigilance Expert - Remote Job at YO AI Labs, New York, NY

  • YO AI Labs
  • New York, NY

Job Description

Job Description

Job Description

Job Title: Pharmacovigilance Expert

Job Type: Contractor
Location: Remote

Job Overview

We are seeking experienced Pharmacovigilance Experts to support an AI healthcare project by reviewing drug safety documentation, evaluating regulatory content, and improving AI-generated outputs. No AI experience is required—your pharmacovigilance expertise is what matters.

Key Responsibilities
  • Review and author DSURs, PSURs/PBRERs, and safety reports.
  • Evaluate safety signals and benefit-risk assessments.
  • Ensure compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
  • Analyze aggregate safety data and reconcile case information.
  • Review MedDRA coding, causality, seriousness, and expectedness.
  • Provide structured feedback to improve AI-generated content.
  • Maintain high standards of quality and regulatory compliance.
Required Skills
  • Pharmacovigilance
  • Drug Safety
  • DSUR/PSUR/PBRER Review
  • ICH E2F & ICH E2C(R2)
  • GVP Guidelines
  • Signal Management
  • Benefit-Risk Assessment
  • MedDRA Coding
  • Safety Data Analysis
  • Regulatory Documentation
  • Strong Written Communication
  • Attention to Detail
Preferred Qualifications
  • 5+ years of pharmacovigilance or drug safety experience.
  • Experience with DSURs, PSURs/PBRERs, and aggregate safety reports.
  • Strong knowledge of ICH E2F, ICH E2C(R2), and GVP.
  • Experience with signal management and safety data review.
  • Degree in Pharmacy, Medicine, Nursing, Life Sciences, or related field.
  • Experience in clinical safety, post-marketing surveillance, or CRO/pharmaceutical environments is a plus.

Job Tags

For contractors

Similar Jobs

Simular

Software Engineer Intern Job at Simular

 ...be based in any of those locations, with priority determined according to the order of listing. What youll do As a Software Engineer Intern at Simular, youll work closely with our founding team to help bring AI agents into the real world. Depending on your skills... 

Pacific Pros

LAWA Construction Inspector, Mechanical Job at Pacific Pros

 ...Description Job Description Pacific Pros is seeking Mechanical Construction Inspector for Los Angeles World Airport (LAWA). Work...  ...typical dayshift is 6:00am 2:30pm or 5:00am 1:30pm M-F; night shift is 10:00pm 6:30am Sun Position Description Summary... 

American Tire

Delivery Driver (non CDL) Job at American Tire

American Tire Distributors - - Responsibilities: Deliver products to customers on time with professional interaction; Unload and stage products at customer's location; Collect payments from customers; Maintain required delivery paperwork; Adhere to safety and transportation...

Korte

Site Safety and Health Officer (SSHO) Job at Korte

 ...The Korte Company is seeking an experienced Site Safety and Health Officer (SSHO) willing to travel up to 100% for commercial/government construction projects to maintain safety for every aspect of the project. Safety is critical to the success of our construction projects... 

EctoHR

Audio Visual Technician Job at EctoHR

 ...service event production company specializing in high-quality audio-visual solutions for live events, corporate events, and business...  ...execution, and exceptional client service. The Audio-Visual Technician The Audio-Visual Technician will be responsible for...