Pharmacovigilance & Safety

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Our vigilance team

Full service vigilance support

Our vigilance team is comprised of physicians, pharmacists and life science professionals. Our experts provide full vigilance support for products such as generics, innovators and advanced therapies. Since 2003 we have delivered comprehensive, end-to-end high-quality pharmacovigilance services to our clients and we have also expanded our services to other vigilance categories such as medical device vigilance, veterinary pharmacovigilance and cosmetovigilance.

From our strategically located European global hubs, we offer cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety (medical device vigilance, vetvigilance, cosmetovigilance). In addition, we have highly skilled experts in multiple countries to better serve your local needs with no subcontracting.

The Excelya advantage

We have implemented a specialized recruitment approach to attract the right talent for the right pharmacovigilance tasks globally and regionally. Our strength is in our people, who possess strong academic backgrounds, deep knowledge of legislation, years of hands-on experience in pre- and post-approval projects for large and mid-size pharma, device manufacturers, etc. Year after year, high retention rates secure continuity and are a basis for expansion. We add not only value to your system but build and sustain your image and reputation.

What we offer

A complete range of vigilance services

Post Marketing Pharmacovigilance Support

  • Set-up and implementation of Pharmacovigilance System, including writing/review of SOPs and preparation/maintenance of Pharmacovigilance System Master File (PSMF)
  • Provision of Qualified Person for Pharmacovigilance (QPPV) in Europe, Turkey, Middle East and African Region
  • 24/7 Pharmacovigilance cover
  • Provision of Local contact person for Pharmacovigilance/ Local QPPV in multiple countries
  • International Literature Review and Local Literature Review
  • ICSR handling: triage, assessment, MedDRA coding, processing
  • Inhouse Safety Database
  • Electronic expedited reporting (e.g. through EudraVigilance)
  • Registration and maintenance of product information in XEVMPD
  • Safety signal detection and Management
  • Aggregate reports (PSUR/ PBRER/ PADERs)
  • Operation of Risk Management System (RMS), including the writing of Risk Management Plan (RMP) and the preparation of materials for Risk Minimisation Activities
  • Direct Healthcare Professional Communication (DHPC) management
  • Controlled Distribution Activities as per Risk Management Plan
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
  • Training
  • Regulatory Intelligence Services
  • Authority Website Monitoring

Clinical Trial Safety

  • Safety review/preparation of safety content for clinical trial documents (including Protocol, SAP, CSR)
  • Preparation of Safety Monitoring/Management Plans for clinical trial conduct
  • Individual case safety report (ICSR) processing for Serious Adverse Events (SAEs)
  • Inhouse Safety Database
  • Expedited reporting (e.g. through EudraVigilance)
  • Aggregate report preparation and reporting (e.g. DSUR)
  • Training

Veterinary Pharmacovigilance

  • Set up and implementation of Pharmacovigilance System, including writing/review of SOPs
  • Creation and Maintenance of the Detailed Description of the Pharmacovigilance System (DDPS)
  • Provision of Qualified Person Responsible for Pharmacovigilance (24/7 cover)
  • Adverse event processing and reporting and efficient handling of communication of safety alerts (off-label, lack of efficacy, potential environmental problems)
  • Preparation/Writing/Submission of PSURs
  • Safety signal detection and management
  • Screening of literature (both Global and Local) for identification of adverse events
  • Safety Data Exchange Agreements (SDEAs) set up and maintenance
  • EudraVigilance set-up, maintenance & registration
  • EudraVigilance Veterinary Medicinal Product Dictionary (EVVetMPD) maintenance
  • Training

Medical Device Vigilance

  • SOP creation and maintenance
  • Collection and follow-up of events
  • Investigation and assessment of Incidents and near-Incidents
  • Screening of literature for identification of events with medical devices
  • Reporting Incidents with Manufacturer’s Incident Report
  • Preparation and submission of Periodic Summary/Trend Reports
  • Implementation and reporting of Field Safety Corrective Action
  • Preparation, translation, distribution to receivers and submission to Health Authorities of Field Safety Notices
  • Training

Cosmetovigilance

  • SOP creation and maintenance
  • Assist Responsible Person within EU for safety related tasks
  • Preparing Safety Assessment Reports for placing cosmetic products on the market
  • Provide market surveillance system for Serious Undesirable Effects (SUEs)
  • Handling Undesirable Effects / Serious Undesirable Effects (SUEs – SUE Form A)
  • Causality Assessment
  • Evaluation of trend or signal detection
  • Safety Data Exchange Agreements (SDEAs) set up and maintenance
  • Training

Training

  • Client staff training on pharmacovigilance or other product safety vigilance focused on the specific needs and tailor-made to the client
  • Training on audits and inspections
  • Excelya training programs on specific vigilance topics

Pharmacovigilance Auditing

Excelya’s Pharmacovigilance and Safety department has a dedicated, experienced and qualified team in order to provide services for assessing the performance and quality of pharmacovigilance activities. Our services include:

  • Pre- audit and Pre-inspection preparation and support
  • PV system Auditing
  • Gap analysis on SOP and PV system