Pharmacolvigilance Brochure

2. Freyr Pharmacovigilance Solutions and Services
Freyr provides end-to-end solutions for your
pharmacovigilance nedds
We offer a comprehensive set of functional
capbilites in a Global
Delivery Model

3. Overview
Supported by our acquired expertise and
domain knowledge, Freyr offers extensive
Pharmacovigilance Services that help cement
your Pharmacovigilance Processes by enhanc-
ing process efficiency and reducing cost pres-
sures - offering value, reliability and ensured
regulatory compliance through deployment
of dedicated service teams that work towards
the unified goal of efficiency enhancement
and cost reduction.
We offer an array of Pharmacovigilance
Services, ranging from collection of data,
processing and medical reviews, safety
writing, reporting through report writing,
along with signal detection and analysis. Freyr
works with you via a partnership model, which
offers you the advantage of benefiting from
our acquired expertise, global reach, quality
systems approach, multidisciplinary safety
expertise and adhering to reporting timelines
of EMEA, FDA, MHRA, and other regulatory
authorities.
Assured Quality, Reliability and Compliance
Freyr has acquired skills in implementing
effective processes and executing robust
work-flows, gaining global recognition on the
way by providing high-quality Pharmacovigi-
lance Services to Pharmaceutical Companies.
We provide end-to-end Pharmacovigilance
Services across a broad range of Therapeutic
Areas spread across all phases of clinical
development with a consistent and rigid
adherence to delivering high-quality outputs
meeting more than 99% compliance with
regards to regulatory deadlines, increased
reduction in error rate and increased accuracy
rates that are delivered by adhering to lean
Six Sigma processes - delivering increased
case handling per person per day.
Freyr Pharmacovigilance Services
MEDICAL/SAFETY LITERATURE SERVICES

4. Freyr Pharmacovigilance Services Portfolio
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2
Case Management and Medical Review
Receive cases from various sources
Case Initiation AE
Triage
Data Entry, MedDRA Coding
Adverse Event Labeling
Narrative Writing
Quality Check
Review source documentation
Confirm Seriousness
Confirm Expectedness
Review & Modify comments
Identify SUSAR/SUA’s
Periodic search and review on:
Articles
Manuscripts
Abstracts
Excerpts
Bibliographic Searches for (ICSR)
Medical/ Safety Literature Services

5. Freyr Pharmacovigilance Services Portfolio
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4
Global Aggregate Report Development
Signal Detection & Analysis
Global Periodic Safety Reporting (PSUR, PADER, PBRER)
Provide support for ASR/DSUR
Review source data
Scientific/Medical Assessment of case
Medication Error and Drug Abuse/Misuse Reporting
Toxicology Report Management
Medical writing support for report generation
Risk management associated reports
Signal Generation and Detection
Signal Analysis
Determination of causality
Evaluation of frequency & strength
Tier 1:
Routine proactive signal identification, prioritization,
analysis and reporting
Tier 2:
On-Demand pro-active signal detection and data mining
Tier 3:
Strategic Risk Management Planning
We provide a Tier based approach in Signal Detection:

6. Copyright © 2013 Freyrinc contactus@freyrinc.com
US : 103 Carnegie Centre, Suite 300, Princeton, NJ - 08540, Phone: +1 908 345 5984
India : 606, Navaketan Complex, S.D. Road, Hyd - 500003, Phone: +91-40-40117020
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