About Company
PPD is a leading global contract research organization, celebrating 25 years of providing discovery and development services and drug lifecycle management. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe, effective therapeutics to patients and maximize returns on their R&D investments.
We seek to attract the best and the brightest talent by providing a stimulating and challenging environment. Our employees take pride in delivering innovative ideas, exceptional service and consistent quality to our clients. We understand our employees are the key to our success, and we acknowledge and reward their excellence.
Description:
Duties and Responsibilities
* Coordinate serious adverse event (SAE) processes and database activities
* Develop an understanding of budgets and forecasts for assigned projects
* Familiar with and understand PPD SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues.
* Effectively interface with project teams, the client company and investigators regarding SAE activities.
* Prepare for and attend audits, kick-off and investigator meetings. Demonstrate the ability to prioritize and organize workload
Qualifications
* Bachelor’s degree in Life Sciences or Nursing
* Minimum 2-3 years medical/clinical experience or clinical/safety experience and minimum 1 year SAE processing experience/or clinical safety experience
* In some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications, certified/licensed health care profession and/or relevant research experience may be substituted provided the individual possesses the required knowledge, skills and abilities
Skills and Knowledge
* Competent in the use of Microsoft Word, Excel and PowerPoint
* Safety database skills
* Good knowledge of applicable SOPs, ICH GCP and awareness of pharmacovigilance regulations
* Ability to review SAE data for completeness and prepare patient narratives from appropriate documentation
* Competent at administrative tasks and project administration activities
* General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required to process SAEs
* Good oral and written communication skills and ability to work within a team or independently as required
PPD is an EEOC
Interested and qualified candidates, please write in to kevin.cheng@ppdi.com
Job:
Safety Specialist (Based in Singapore)
Primary Location:
Singapore
Key Skills:
Pharmacovigilance
Experience:
2 - 5 years
Role:
Other Pharma
Key Skills:
• Pharmaceutical/ Biotechnology
• Health Care
Organization:
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