Medical Safety Reporting Pharmacovigilance Expert

About OpenTrain

OpenTrain is the #1 platform for finding and building careers in AI training and data labeling. OpenTrain AI is recruiting contractors for specialized work that helps shape how advanced AI systems understand expert tasks and produce reliable outputs.

As an OpenTrain contributor, you can build a profile around credible AI training experience, discover projects aligned with your expertise, and apply in minutes. Creating an OpenTrain account is free.

• Contractor and part-time opportunity
• 20+ hours per week
• Hourly pay of $140-$190 USD
• Open to candidates in the United States, Canada, and France

About AI Training and Pharmacovigilance Work

AI training is the human side of building artificial intelligence. Experts prepare examples, review model outputs, write reference responses, and create evaluation standards so AI systems can perform specialized work more accurately.

In this role, your pharmacovigilance judgment will help define how an AI agent handles clinical safety information, aggregate reporting, benefit-risk interpretation, and complex case review.

• Contribute to cutting-edge AI development using professional expertise
• Create prompts, reference outputs, and evaluation rubrics
• Perform work remotely with flexible project participation

The Role

OpenTrain is seeking a Medical Safety Reporting and Pharmacovigilance Expert to generate and validate the safety layer of clinical data rooms and create evaluation work for an AI agent. The role covers both pre-commercial and post-commercial aggregate safety reporting, including Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).

You will apply experienced benefit-risk judgment to cumulative safety information, exposure estimates, and signal detection results. The work also includes detailed review of adverse events, serious adverse events, patient narratives, discontinuations, protocol deviations, and fatal cases.

• Work type: contractor and part time
• Time requirement: 20+ hours per week
• Pay range: $140-$190 USD per hour
• Primary language: English
• Eligible countries: United States, Canada, and France

What You'll Do

You will combine precise safety reporting with structured AI evaluation. Your work will help establish dependable examples and scoring criteria for an AI agent performing pharmacovigilance reporting tasks.

• Generate and validate the safety layer of clinical data rooms
• Review adverse event data and serious adverse event records
• Review patient narratives, discontinuations, and protocol deviations
• Author full DSURs, PBRERs, and their component sections
• Design prompts, golden outputs, and evaluation rubrics for an AI agent
• Interpret benefit-risk information using cumulative safety data
• Apply exposure estimates and signal detection output in safety assessments
• Complete full fatal-case workups
• Distinguish investigator causality from sponsor causality

Required Qualifications

This role requires deep professional experience in medical safety reporting and pharmacovigilance. Candidates must be able to demonstrate expert judgment across development-stage and post-commercial safety work, as well as the ability to translate that judgment into clear AI evaluation materials.

• At least five years of relevant professional experience; deeper experience is preferred
• MD, PharmD, PhD, or equivalent medical or pharmaceutical qualification
• Authorship of aggregate safety reports spanning both pre-commercial DSUR and post-commercial PBRER reporting
• Strong understanding of active benefit-risk interpretation
• Experience with cumulative safety data, exposure estimates, and signal detection output
• Experience conducting full fatal-case workups
• Ability to assess both investigator and sponsor causality
• Ability to author precise reporting content
• Ability to create prompts, reference outputs, and evaluation rubrics

Who Should Apply

This opportunity is suited to an experienced pharmacovigilance professional who has worked across both development-stage and post-commercial reporting. Familiarity with DSUR and PBRER structures, component sections, clinical safety narratives, and serious safety cases will support success.

The source information identifies the role as entry level, but the stated qualification requirements call for at least five years of relevant professional experience and advanced medical or pharmaceutical education. Candidates should use the detailed requirements above to assess their fit.

• Medical safety reporting specialists
• Pharmacovigilance experts with DSUR and PBRER authorship experience
• Professionals experienced in fatal-case review and causality assessment
• Experts who can convert domain judgment into AI evaluation criteria

Build Your AI Training Career with OpenTrain

Every major AI system depends on people who can prepare, review, and evaluate high-quality examples. OpenTrain helps professionals turn specialized expertise into meaningful AI training work and build a durable portfolio over time.

Create your free OpenTrain profile to present your experience, discover relevant opportunities, and apply to this pharmacovigilance-focused project.

• Create a free OpenTrain account
• Showcase specialized medical safety expertise
• Find AI training projects matched to your professional background
• Apply in minutes and grow a long-term AI training portfolio