A Drug Safety Associate plays a pivotal role in ensuring medicines

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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. 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).


Soniya Gurg writes content about Clinical research services, Drug safety associate,Clinical research organization,contract research, contract research organisations, contract research company. For more information visit at: http://www.qsi.in/.


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