SERCN– The Drug Safety Associate, in essence, is accountable and reports to three distinct clients:
1. The immediate employer
2. The sponsor/client on whose behalf the project has been undertaken by the employer and
3. regulatory authorities.
A Drug Safety Associate (DSA) plays a pivotal role in ensuring medicines are ultimately safe for human or animal consumption. The DSA provides specialized technical and process-related support to drug safety and medical monitoring initiatives. The DSA is responsible for documenting and tracking adverse events and serious-adverse events reports and processing them in accordance with employer, sponsor and government safety regulations and policies.
Some of the responsibilities of a Drug Safety Associate may include:
- Checking the accuracy and cohesiveness of adverse event and serious adverse event reports from clinical trials and prioritizing them
- Preparing and reviewing safety reports
- Responding to product safety inquiries originating from regulatory authorities, within his/her own organization, healthcare professionals and/or patients
- Assessing patient eligibility for clinical trials
- Entering data into safety databases and reporting systems
- Processing adverse event reports from various sources to ensure compliance with regulations
- Initiating quality assurance analysis on specific cases
- Reviewing work of other DSAs
- Representing safety operations at meetings, presentations, training programs and the like
- Preparing comprehensive reviews of adverse or serious-adverse events
- Highlighting potential sources of product litigation
- Processing case – related information
- Writing case narratives
- Ensuring compliance with the MedDRA (Medical Dictionary for Regulatory Activities) coding, retrieval and analysis terminology
- Performing safety audits of clinical data
- Contributing to the development and training of staff members
The DSA may have a diploma or degree (associate’s, bachelor’s or above) in medicine, life sciences, pharmacy, nursing or a related discipline. S/he is usually an expert on drug safety and the drug development process. The Drug Safety Associate (DSA) also demonstrates above-average time management, communication, people, analytical and problem-solving skills.
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S/he may also be familiar with US and international drug safety and pharmacovigilance principles and regulations, MedDRA coding principles, regulatory timeline requirements, submission criteria, technical requirements and/or guidelines of the CIOMS (Council for International Organizations of Medical Sciences).