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Drug Safety Managers

Kelly Scientific Resources works in partnership with many leading organisations across a variety of industry sectors and we are always looking for high caliber candidates.

Drug Safety Managers/Associates are responsible for monitoring the clinical safety of projects/products. They ensure compliance with relevant regulations and Standard Operating Procedures (SOPs) in all aspects of drug safety data processing and reporting.

Responsibilities of the Drug Safety Manager could include any or all of the following tasks:

  • Ensure integrity of the safety and quality of the clinical trials.
  • Verify the medical and clinical consistency of reported study data
  • Develop, review and update drug safety forms & templates
  • Collect, document, and process adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) to ensure regulatory compliance.
  • Participate in the planning and preparation of the AE section of protocols for clinical studies, review of CRFs, and investigator meeting presentations.
  • Coding of AEs in MedDRA
  • Define and apply case quality reviews to ensure sound medical safety data documentation.
  • Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.

Requirements may include:

  • Pharmacy, Nursing, Life Science, or other health-related field with proven experience in drug safety.
  • Strong verbal and written communication skills
  • Knowledge of domestic and international drug safety regulations, industry practices and standards as well as clinical knowledge in appropriate therapeutic area is preferred.
  • Proficiency in all Microsoft applications; experience with data entry into drug safety databases strongly desired
  • Ability to organise workflow activities, multi-task and possess excellent decision-making skills.

If you are seeking temporary or permanent opportunities as a Drug Safety Manager, then we would like to hear from you. For further enquiries contact your nearest Kelly Scientific Resources branch:

Adelaide: 08 8409 8821 or email ksrsa@kellyservices.com 
Brisbane: 07 3405 3326 or email ksrqld@kellyservices.com 
Melbourne: 03 9204 4204 or email ksrvic@kellyservices.com 
Perth: 08 9229 1888 or email ksrwa@kellyservices.com 
Sydney: 02 9246 6030 or email ksrsyd@kellyservices.com 

 

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