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PHARMACOVIGILANCE & MEDICAL SCIENTIFIC WRITING
Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is an ISO 21001:2018 Certified health science Institute & globally acclaimed, also certified with copyright approval from IPR Government of INDIA. GIHS have international certification from UASL UK for Quality Control Management System.
WHY CHOOSE US
Pharmacovigilance Training Program also known as Drug Safety. This is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function monitored by the physicians. Medication errors such as overdose, and misuse and abuse of a drug, are also of interest because they may result in an ADR. This GIHS Pharmacovigilance Program designed to provide total overview and skill globally in the field of clinical research and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. This program will enhance you on medical & scientific writings, you will be expert in Medical writing which involves the development and production of print or digital documents that deal specifically with medicine or health care. The profession of medical writing calls for knowledge in both writing and science, combining a writer’s creative talent with the rigor and detail of research and the scientific process.
SYLLABUS
PHARMACOVIGILANCE
Introduction of Pharmacovigilance
Standard Terms and Terminology in Pharmacovigilance Medical Evaluation of Adverse Events in Pharmacovigilance Adverse Event Reporting System and Form Diagnosis and Managements of ADRs / Medical Evaluation of AE
Global Perspective of Pharmacovigilance Single Case Processing / Case Narrative Writing
Quality System in PV / Expedited Reporting Criteria PSUR & PBRER / PV Database and Signal Detection Risk Assessments & Management
medDRA
Regulatory Guideline @ Laws in PV / SOPS in PV PV Auditing and Inspection / Regulatory Aspects in PV MEDICAL/SCIENTIFIC WRITING
*Fees subject to taxes & exchange rates.
*Fees subject to taxes & exchange rates.
Medical writing in pharmacovigilance involves creating clear and accurate documents related to drug safety and regulatory reporting. This includes writing safety narratives, periodic safety update reports, and other relevant documents.
To get a pharmacovigilance certificate, you can enrol in online courses or training programs such as the one offered by us at GIHS. Our program covers topics such as drug safety, adverse event reporting, regulatory requirements, and pharmacovigilance systems.
Yes, a pharmacovigilance certificate is worth it, especially for individuals seeking to advance their careers in drug safety and regulatory affairs. Certification demonstrates a commitment to professional development and can enhance job prospects in the pharmaceutical and healthcare industries.
To become a pharmacovigilance scientist, you need a relevant scientific or medical background. Continuing education in pharmacovigilance and obtaining relevant certifications can further enhance your qualifications.
To become a medical writer, you need an educational background in a relevant field such as life sciences, pharmacy, or medicine. Specialized courses or certifications in medical writing can also be beneficial for career advancement.
