The Pharmacovigilance department of Zeincro is comprised of qualified personnel and offers a complete range of Pharmacovigilance services to its clients summarized below:

Preparation and implementation of company Pharmacovigilance System

Including:

• Standard Operating Procedures (SOPs) writing and review.
• Writing and submission to the Health Authorities of Detailed Description of the Pharmacovigilance System (DDPVS).
• Consultancy services concerning working practices and legislation on Pharmacovigilance.

Collection, Processing and Evaluation of Adverse Events (AEs)

Including:

• Collection, assessment and submission to Health Authorities of AE reports originating from Health care professionals, consumers, Health Authorities and literature.
• Implementation of electronic reporting of Individual Case Safety Reports (ICSRs) through EudraVigilance.
• International and Local Literature review for screening of AEs.
• Database build and statistical analysis of AEs occurrence.
• Medical evaluation of the Pharmacovigilance data and Signal Detection in order to carry out the Risk - Benefit assessment.
• Preparation of Periodic Safety Update Reports (PSURs) and submission to the Health Authorities.
• Construction and Maintenance of archiving system for PSURs and AEs.

Risk Management System (RMS)

Including:

• Preparation and submission of Risk Management Plan (RMP).
• Preparation, translation and submission to Health Authorities of Dear Health Care Professional Letters.
• Crisis Management System.

Training in Pharmacovigilance

Trainings:

• Of all company employees concerning Pharmacovigilance obligations (1 hour).
• Of company's Pharmacovigilance Department (2 - 3 days).
• Tailor - made training seminars to suit your needs in Pharmacovigilance training

Audits / inspections in Pharmacovigilance

• Training on audits and inspections.
• Performing Audits.
• Preparation for Inspections
• Consulting on Audits and Inspections reports

Clinical Safety

• Collection and assessment of Adverse Events originating from interventional or non - interventional clinical trials
• Submission of SUSARs to the Health Authorities, the National Ethics Committee, the Hospital Scientific Committees and the Investigators
  
• Writing and Submission to the Authorities of aggregate Clinical Safety Reports

For each project, a project team is assigned. Depending on the project's needs, the team is comprised of Safety Officer(s), Biostatistician(s), Medical Advisor(s) and the Training department. The project's metrics on company and regulatory compliance are controlled by the Quality Assurance Manager.

Zeincro's reliable expert team guarantees high quality Pharmacovigilance services based on good knowledge of the legislation and excellent team work.