DRUG SAFETY / PV
Manufacturing bulk drugs and Class II and III Medical devices is highly regulated by the FDA and DEA. Developing safe drugs and devices for mankind is the truth of this serious business. Of all the steps, ascertaining the safety of drug is the most crucial one as an unsafe drug can do more harm to the body than the disease itself. So, it becomes most important for the pharmaceutical company to identify the safety information about the drug/device in a timely manner to avoid any future uncertainty. To do so and ensure the safety of underdevelopment drug/device, the most essential step is to thoroughly collect as well as analyze its safety information data. A well collected and analyzed data is required for the success of clinical research and to maintain the post-marketing drug licenses.
At Aptitude Solution , we understand the criticality of patient safety, drug safety and pharmacovigilance for every clinical research. We offer drug safety and pharmacovigilance consulting services throughout the life cycle of a drug/device development spanning from preclinical, clinical to post-marketing. Our team of experienced drug safety and pharmacovigilance experts can assist you in evaluating and managing the safety concerns of your product.
We will be responsible for the day-to-day processing of Adverse Event (AE) and Product Complaint (PC) cases in the Medical Information Call Center (MICC). We will collect information related to AEs and PCs and document the information in the appropriate reporting form and database. we will provide general support of the MICC, as well as other responsibilities supporting the client.
- Perform initial intake of AE/PC cases that are directed to the MICC by phone, fax, email, mail, directly from client representatives, and any other means
- Write a detailed AE narrative that includes a medical history and description of the events
- Perform AE and PC follow-up as required by individual clients
- Document casework in IRMS proficiently
- Utilize client database for AE case processing where required
- Generate and maintain monthly/weekly/periodic AE/PC reporting for clients as needed
- Perform literature report searches
- Serve as backup for Medical Information Coordinator team as case volume allows
