NOGEN Pharmed: Science in action, vigilance in practice
Pharmacovigilance, which encompasses the knowledge and activities involved in tracking, evaluating, reporting, and preventing drug side effects or other drug-related issues, is a crucial function at NOGEN Pharmed Caspian Pharmaceutical Company. Our pharmacovigilance unit meticulously monitors drug side effects once on the market, prioritizing patient health and ensuring drug safety. This commitment reflects our deep care and value for our patients.
Goals of the Pharmacovigilance Unit at NOGEN Pharmed Caspian Company:
Rapid diagnosis of unknown drug side effects and interactions.
Determining any increase in the frequency of drug side effects.
Identifying risk factors and causes of drug side effects.
Main Duties of the Pharmacovigilance Unit at Nogen Pharmed Caspian Company:
Collecting Reports of Side Effects:
Establishing a database for storing and retrieving information.
Collecting side effect reports from doctors, pharmacists, patients, and other sources.
Documenting and classifying these reports within the database.
Evaluation of Reports:
Collecting and evaluating information, ensuring accuracy and validity.
Comparing new reports against the current information in the database.
Assessing the severity and frequency of side effects.
Preparation of Safety Reports:
Develop periodic case reports on drug safety.
Presenting these reports to the company’s regulatory authorities, internal stakeholders, and other pertinent parties.
Supervision of Post-Marketing Studies:
Designing and conducting epidemiological studies to assess long-term risks associated with drugs.
Overseeing post-marketing clinical trials.
Coding pharmaceutical products to determine the causal relationship between drug usage and reported complications.
Collaboration with Regulatory Authorities:
Establishing relationships with international organizations involved in pharmacovigilance, such as the World Health Organization (WHO). This collaboration is crucial in ensuring compliance with regulations and maintaining the highest drug safety standards.
Organizing meetings in hospitals, academic institutions, and professional associations to elucidate pharmacovigilance principles and emphasize the importance of reporting.
Communication with Health Professionals: Engaging with physicians, pharmacists, and other health professionals to gather comprehensive information regarding drug side effects in the fields of clinical medicine, clinical pharmacology, and clinical toxicology.
Training:
Educating company employees about pharmacovigilance processes.
Training doctors and pharmacists on how to report side effects.
Proactive Signal Detection and Data Mining
This unit proactively searches for safety signals using advanced data mining of large databases (e.g., electronic health records, claims data, social media) to identify potential issues not readily apparent from individual reports.
Risk Minimization Strategies
This unit develops and implements risk minimization strategies, including educational materials for healthcare professionals and patients and controlled access programs for specific medications.
Pharmacovigilance in Product Lifecycle
This unit integrates pharmacovigilance throughout the product lifecycle, from preclinical development to post-market surveillance, including incorporating safety considerations into clinical trials and collecting/analyzing safety data.
Global Collaboration and Data Sharing
This unit participates in global pharmacovigilance initiatives, sharing safety data with regulatory authorities and organizations like the WHO to facilitate early signal detection and promote global harmonization.
Pharmacovigilance Unit
NOGEN Pharmed: Vigilant monitoring, for patient well-being
Importance of Pharmacovigilance:
Protecting patients by identifying and mitigating the risks associated with medications.
Upholding the company’s reputation by fostering trust among patients, healthcare professionals, and regulatory agencies.
Reducing costs related to adverse effects through early identification of issues and prevention of serious complications.
Improving drug labeling by timely updating information on side effects as needed.
Our qualified and licensed pharmacovigilance personnel (QPPV):
Our team of clinical pharmacists, drawing on their extensive knowledge and experience in clinics and hospital settings, is fully aware of potential drug side effects. We are dedicated to providing you with the best possible guidance. The primary objective of the Medicines Safety Monitoring Unit is to guarantee that your medications are both safe and effective, providing you with a treatment experience that is as safe and high-quality as possible. At the Medicines Safety Monitoring Unit, we are dedicated to safeguarding your health. Your trust is our most valuable asset, and we are resolute in our commitment to ensuring your medications are safe and effective.
My name is Dr. Hoda Ebrahimi, and I currently serve as a Pharmacovigilance Scientist, where I manage a comprehensive portfolio of activities related to drug safety and risk management. My responsibilities encompass the systematic collection, analysis, and interpretation of adverse event data derived from various sources, including clinical trials, post-marketing surveillance, and spontaneous reports. This involves leveraging scientific literature, specialized databases, and pharmacovigilance reporting systems to ensure the ongoing safety and benefit-risk assessment of medicinal products. My doctoral degree in Microbiology at Tehran University instilled in me the critical thinking skills, scientific rigor, and comprehensive understanding of biological systems and pharmacology that are crucial for effective pharmacovigilance.
Should you wish to maintain communication, I would be delighted to hear from you. Please feel free to contact me via email at: [email protected] at your convenience. For any inquiries that require immediate attention by phone, you may reach me at: +98 21 88684105 by selecting option 102.
