Drug safety associate is the entry level employment for pharmacy or life science graduate in the field of drug safety. Drug safety associate is primarily engaged in case creation, reviewing for minimum safety information (MSI). A pharmacy degree, bachelors degree in science, life sciences, medical, nursing or healthcare from a reputed educational institute and a short period of on-field training is required before applying for a job as a drug safety officer or associate.
A drug safety associate also monitors all the post-marked products, ensuring that they are safe for the people. The safety officer is actively involved in doing assessment of adverse event writings, writing update reports on safety, conducting quality checks on write-ups penned by other drug safety officers and sending drug related case reports to other branch offices as and when they are needed.
As a drug safety associate, the uniqueness and the specified nature of the job aspires many degree holders to pursue their career in this line. Advanced medical technology and progression in safety features have made it easier to identify drug related issues and evoke interest of science graduates.
What is the career progression like in the drug safety profession?
As soon as an individual obtains an experience of 2-3 years as a drug safety associate and develops the expected skill sets (narrative and scientific writing, medical coding and superior understanding of medical terms, ICH-GCP, essential understanding of regulatory affairs and compliance etc) he/she can go on to grow to be a Drug Safety Scientist.
Qualified Person for Pharmacovigilance QPPVs jobs are mainly concerned with marketed drugs and those about to be authorized, but as QPPVs are considered by many to be subject matter experts, their expertise is utilized across the discipline and wider business. These senior pharmacovigilance roles will only be held by very experienced professionals and their focus is to understand, plan for and advise upon the regulations and requirements that companies must adhere to. This is a highly strategic appointment and one of great importance.
Aspiring drug safety professionals can get more information on drug safety from:
1. Online ‘Index to Drug Specific Information: includes only drugs that have been the subject of a Drug Safety Communication or equivalent (previously known as Early Communication/Health Care Professional Information Sheet), and provides direct access to the content of each communication.
2. Med Watch Alerts: contain actionable information that may affect both treatment and diagnostic choices and provide timely medical product information. The MedWatch gateway provides opportunities to sign up for MedWatch email updates, subscribe to RSS Feed safety alerts, and follow MedWatch on Twitter.
3. Daily Med: a website developed with the National Library of Medicine, gives physicians and patients electronic access to FDA-approved drug labels. The presentation includes a ‘tabbed’ format, providing quick access to specific portions of product labeling, including reproductions of the carton and container.
4. Drugs@FDA: an online database of approved drug products, allows a search for information regarding drugs and biologic products by drug name or active ingredient. Electronic links to the product approval history, approval letters, reviews and related documents, labeling information, REMS information and medication guides are provided.
5. Complete transcripts of FDA Advisory Committee meetings, and schedules of upcoming meetings and agendas, are available online.
