A Drug Safety Associate Plays A Pivotal Role In Ensuring Medicines

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).

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