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Aggregate In Pharmacovigilance Jobs in Florida (NOW HIRING)

Pharmacovigilance Expert Job Type: Contractor Location: Remote Job Overview We are seeking ... Experience reconciling aggregate safety data with case-level information. * Advanced degree in life ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

Pharmacovigilance Expert Role Type: Contractor Location: Remote micro1 is engaging ... Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level ...

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Aggregate In Pharmacovigilance information

What are the key skills and qualifications needed to thrive as an aggregate in pharmacovigilance?

To thrive in an Aggregate role in Pharmacovigilance, you need a solid background in life sciences or pharmacy, strong analytical abilities, and experience with safety data analysis and regulatory reporting. Familiarity with pharmacovigilance databases (such as Argus or ArisG), signal detection tools, and an understanding of global regulatory guidelines (e.g., ICH, EMA, FDA) are typically required. Excellent attention to detail, organizational skills, and effective communication are essential soft skills for interpreting complex data and collaborating across teams. These competencies are crucial for ensuring accurate safety reporting, regulatory compliance, and the protection of patient health.

What are some common challenges faced by professionals working in aggregate reporting within pharmacovigilance?

Professionals involved in aggregate reporting in pharmacovigilance often encounter challenges such as managing large volumes of data from multiple sources, ensuring compliance with evolving global regulatory requirements, and meeting strict submission deadlines. Coordinating with cross-functional teams—such as clinical, regulatory, and safety departments—is essential for gathering accurate information and maintaining data consistency. Attention to detail and strong organizational skills are crucial to ensure that periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate reports are comprehensive and error-free.

What is the difference between Aggregate In Pharmacovigilance vs Pharmacovigilance Associate?

AspectAggregate In PharmacovigilancePharmacovigilance Associate
CredentialsTypically requires a degree in life sciences, pharmacy, or related field; certifications like PV training are commonSimilar educational background; often requires PV-specific training or certifications
Work EnvironmentFocuses on data analysis, signal detection, and reporting of safety data at a higher levelInvolves data entry, case processing, and supporting safety reports
Employer & Industry UsageUsed in pharmaceutical companies, CROs, and regulatory agencies for safety data analysisCommonly employed in similar settings for case management and data entry

In summary, Aggregate In Pharmacovigilance primarily handles data analysis and safety signal detection, requiring advanced skills in data interpretation. Pharmacovigilance Associates focus on case processing and data entry tasks. Both roles require relevant certifications and work within the same industry environment, but differ in scope and responsibilities.

What is aggregate reporting in pharmacovigilance?

In pharmacovigilance, aggregate reporting involves compiling and analyzing safety data from multiple individual adverse event reports over a specific period to identify safety signals and trends. Pharmacovigilance professionals use tools like safety databases and statistical methods to prepare periodic safety update reports (PSURs) and aggregate reports required by regulatory authorities.

What are popular job titles related to Aggregate In Pharmacovigilance jobs in Florida?

For Aggregate In Pharmacovigilance jobs in Florida, the most frequently searched job titles are:

What cities in Florida are hiring for Aggregate In Pharmacovigilance jobs?

Cities in Florida with the most Aggregate In Pharmacovigilance job openings:

Pharmacovigilance Expert - Remote

YO AI Labs

Miami, FL • Remote

$70 - $80/hr

Full-time

Posted 9 days ago


Job description

Job Title: Pharmacovigilance Expert

Job Type: Contractor
Location: Remote

Job Overview

We are seeking experienced Pharmacovigilance Experts to contribute their drug safety expertise to an innovative healthcare AI project. In this role, you will help improve next-generation AI systems by reviewing, evaluating, and refining pharmacovigilance documentation, safety reports, and regulatory content. No prior AI experience is required—your pharmacovigilance expertise, analytical skills, and commitment to data quality are what matter most.

Key Responsibilities
  • Author and review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case-level records.

  • Assess safety findings, signal evaluations, and benefit-risk conclusions for accuracy and regulatory alignment.

  • Review reports for compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.

  • Analyze aggregate safety data and reconcile case counts, figures, and inconsistencies across data sources.

  • Evaluate safety conclusions based on new data, events, and regulatory requirements.

  • Provide structured written feedback and rationales to support AI-driven pharmacovigilance tools.

  • Ensure accuracy, completeness, and quality of regulatory safety documentation.

Required Skills
  • Pharmacovigilance

  • Drug Safety Report Authoring

  • DSUR/PSUR/PBRER Review

  • ICH E2F & ICH E2C(R2) Compliance

  • GVP Guidelines

  • Aggregate Safety Data Analysis

  • Signal Management

  • Benefit-Risk Assessment

  • MedDRA Coding

  • Seriousness & Causality Assessment

  • Expectedness Determination

  • Data Reconciliation

  • Regulatory Documentation

  • Structured Written Communication

  • Attention to Detail

Preferred Qualifications
  • 5+ years of pharmacovigilance or drug safety experience within a sponsor, CRO, or consulting environment.

  • Proven experience authoring or reviewing DSURs and/or PSURs/PBRERs.

  • Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.

  • Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis.

  • Experience reconciling aggregate safety data with case-level information.

  • Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent).

  • Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.