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Aggregate In Pharmacovigilance Jobs in Virginia (NOW HIRING)

micro1 AI

Pharmacovigilance Expert

Suffolk, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Roanoke, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Newport News, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Alexandria, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Norfolk, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Chesapeake, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Virginia Beach, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Richmond, VA · Remote

$70 - $80/hr

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

micro1 AI

Pharmacovigilance Expert

Hampton, VA · Remote

$70 - $80/hr

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

micro1 AI

Clinical Pharmacy Technicians

Norfolk, VA · Remote

$70 - $80/hr

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

micro1 AI

Clinical Pharmacy Technicians

Richmond, VA · Remote

$70 - $80/hr

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

micro1 AI

Clinical Pharmacy Technicians

Hampton, VA · Remote

$70 - $80/hr

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

micro1 AI

Clinical Pharmacy Technicians

Suffolk, VA · Remote

$70 - $80/hr

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

micro1 AI

Clinical Pharmacy Technicians

Roanoke, VA · Remote

$70 - $80/hr

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

All JobsAggregate In Pharmacovigilance JobsAggregate In Pharmacovigilance Jobs in Virginia

Aggregate In Pharmacovigilance information

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 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 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 follow regulatory guidelines to prepare periodic safety update reports (PSURs) and aggregate safety data for regulatory submissions.

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 are popular job titles related to Aggregate In Pharmacovigilance jobs in Virginia? For Aggregate In Pharmacovigilance jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Aggregate In Pharmacovigilance jobs in Virginia look for? The top searched job categories for Aggregate In Pharmacovigilance jobs in Virginia are:
What cities in Virginia are hiring for Aggregate In Pharmacovigilance jobs? Cities in Virginia with the most Aggregate In Pharmacovigilance job openings:
Aggregate In Pharmacovigilance jobs near you

Pharmacovigilance Expert

micro1 AI

Suffolk, VA • Remote

$70 - $80/hr

Part-time

Posted 6 days ago

Job description

Role Title: Pharmacovigilance Expert


Role Type: Contractor


Location: Remote


micro1 is engaging Pharmacovigilance Experts to contribute their advanced drug safety expertise on a key customer project. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters. This opportunity is ideal for professionals experienced in authoring and reviewing complex safety reports, passionate about data quality, and committed to clear written and verbal communication.


Scope of Work

  1. Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
  2. Apply expert judgment to assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions in alignment with best practices.
  3. Assess template and structural conformity to ICH E2F and ICH E2C requirements, including proper section content, presentation of cumulative versus interval data, and completeness of appendices.
  4. Reconcile figures and case counts across report sections and data sources, identifying and documenting discrepancies significant for regulatory review.
  5. Evaluate safety conclusions in light of new data or events, and provide clear, structured written rationales supporting your determinations.
  6. Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.


Preferred Qualifications

  1. 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
  2. Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
  3. Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methodology.
  4. Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
  5. Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level information.
  6. Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).
  7. Experience in both development-stage and post-marketing safety reporting, QPPV or deputy QPPV roles, safety committee participation, or AI-assisted safety review tools is a plus.

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