PHARMACOVIGILANCE MANAGEMENT SERVICES

THE CHALLENGES

  • Managing worldwide cases for all product related safety information
  • Complex System and proceses to manage Pharmacovigilance data.
  • Missing data from Literature due to lack in search strategies and tracking
  • Lack of system to handle huge amount of data for different molecules
  • Huge time consumption on processing of big data and time wastage on reviewing the ICSR article multiple times
  • Duplicate case handling – possible missing of data and also overlapping with direct reports from health professionals and clinical studies.
  • High cost of manual entry
  • Missing deadlines of Expedited Reporting
  • Quality issues
  • Training & Documentations

THE SOLUTION - WE OFFER

WE DO NOT PROVIDE JUST THE SERVICES, WE PROVIDE QUALITY ASSURED SERVICES

PHARMACOVIGILANCE CORE ACTIVITIES


  • Collection and management of adverse drug reaction (ADR) data
  • Case processing activities including case Triage, Causlaity assessment, Case entries, MedDRA & WHO DD coding etc.
  • Preparing and development of PSMF, Risk Management Plans (RMPs), PSURs, PBRERs etc.
  • Submitting expedited and aggregate reports
  • Providing Pharmacovigilance Software/Database solution for ICSR management

PHARMACOVIGILANCE MANAGEMENT ACTIVITIES


  • Preparing standard operating procedures (SOPs) and other controlled quality documents
  • Management of internal and regulatory compliance reporting
  • Testing and Validation of Pharmacovigilance processes and systems for compliance
  • Performing trend analyses and predictive modeling for compliance operations
  • Preparation and maintenance of Pharmacovigilance System Master File
  • Preparation and review of safety data exchange agreements
  • Quality and training system management and documentations
  • Audit readiness system support
  • Corrective and Preventative Action (CAPA) implementation

OUR KEY STRENGTHS


  OUR TRAININGS
HTMS - HAROM's TRAINING MANAGEMENT SYSTEM


      OUR SYSTEM
HPMS - HAROM's PHARMACOVIGILANCE MANAGEMENT SYSTEM


     OUR QUALITY
HQMS - HAROM's QUALITY MANAGEMENT SYSTEM

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For Enquiry

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Contact Us

Address: HAROM Solutions
SCO 117-118, Level I
Sector 17B Madhya Marg
Chandigarh-160017
Phone No:- +91 172-4663037 , 9988756469
E-mail: info@haromsolutions.com
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