End to End Pharmacovigilance Services
HAROM Solutions Pharmacovigilance System Management service include End-to-End solution for small, mid and large sized pharmaceutical and biotechnology companies for their regulatory obligations in regards their drug safety. Our team of experts strives to provide each client Pharmacovigilance solutions using inventive, web-enabled technology to tackle key challenges in Pharmacovigilance data management posed by the new legislation using skills and knowledge gained from over 20 years of Pharmacovigilance experience.
Our complete range of solutions for Pharmacovigilance system includes:
- Processing and management of ICSRs including Case intake, Case entry, MedDRA and WHO-DD coding, Triaging, Quality Control, Medical review etc)
- Generation of Regulatory reports including Expedited, PSURs, DSURs etc
- Qualified Person for Pharmacovigilance (QPPV) services
- Literature management and review
- Signal detection and analysis
- Regulatory Reporting
- Audits & Inspections
- Quality & Training Management
Pharmacovigilance Services - MODEL
The end-to-end Pharmacovigilance services by HAROM Solutions allow Pharmaceutical companies and CROs to hone their focus on business activities. Our Pharmacovigilance System model covers all operational Pharmacovigilance services, from processing of ICSRs to expedited and aggregate reporting and safety surveillance. In addition the service model includes the development, execution, and follow-up of risk-management. The service includes appropriate management of the complete Pharmacovigilance system allowing the company to truly rely on our expertise and fulfill all regulatory requirements.
PV SYSTEM
End-to-End Pharmacovigilance service model to manage overall pharmacovigilance functional activities on behalf of the client.
DOCUMENTATION
- Process design and SOP development
- PSMF Preperation
- Quality & Training Documents
SAFETY DATABASE
- E2B Complianced Software
- Integrated MedDRA
- Integrated WHO-DD
- Validation Support
- Automated Reporting
- User fiendly
ICSR MANAGEMENT
- Case Processing
- Case entries
- Triage & Follow-ups
- Causality Assessement
- Narrative Writing
- Medical Reviews
LITERATURE
- Literature management and procssing of ICSRs
- Monthly or adhoc activities
AGGREGATE REPORTING
- Preperation, Review & Submission of:
- PSURs
- DSURs
- PBRERs
RISK MANAGEMENT
- Risk minimization activities
- Prperation of Risk Management Plans
- Risk assessment, Communication & Reporting
SYSTEM MAINTAINENCE
- Quality management
- Training activities
- Document mainainence
- Audit support activitie
HAROM's Capability & Experience
- Team with skill-specific expertise aims to provide research-based solutions which enable faster and better decision-making and drive client-specific business initiatives.
- High productivity & quality
- In-hose training managment
- Global presence
- Customized services
CONTACT US
In order to get a complete overview of what HAROM Solutions can do for you, please send us an email to info@haromsolutions.com to request a demonstration of all the features​
Contact us for help, additional info or assistance and we'll be with you in no time!