Average Salary for this job is $75000 as per www.payscale.com/Canada
This unique program is offered over 4 weeks (one full day per week) and classes can be offered on Saturdays based on the students demand. Please contact firstname.lastname@example.org for more information and registration.
This program includes 5 topics:
1- Introduction to Drug Safety and Pharmacovigilance
2- Good Pharmacovigilance Practices (ICH-GVP)
3- Clinical Pharmacology for ICSR Causality Assessment
4- Drug Safety and Pharmacovigilance Reporting Activities (SUSAR, PBRER, DSUR, Signal Detection)
5- Post Marketing Compliance Activities and Pharmacoepidemiological Studies
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention ofadverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). 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 (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Information received from patients and health care providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. (See Adverse Event Reporting below.)
Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.