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Vacancy details
Vacancy description:
Job Code:
01030
Job Title:
Safety Specialist
Job Category:
Regulatory And Drug Safety
Contract:
Any
Discipline:
Drug Safety, Pharmacovigilance
Country:
United States Of America
Location:
Texas
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
11 Mar 2010
Safety Specialist-01030
Job Category Pharmacovigilance
Primary Location North America-United States-Texas-Austin
Description
The Safety Specialist, working alongside a more experienced member of staff, will coordinate serious adverse event (SAE) processes and database activities, and develop an understanding of budgets and forecasts for assigned projects. He/she must be familiar with and understand PPD Standard Operating Procedures and Working Practice Documents; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues.
He/she, alongside a more experienced member of staff, will effectively interface with project teams, the client and investigators regarding SAE activities. He/she may also prepare for and attend audits, kick-off and investigator meetings. The Safety Specialist must demonstrate the ability to prioritize and organize their own workload, which will be assigned by a more experienced member of staff. All accountabilities of a Safety Specialist are carried out with minimal ongoing supervision of a more senior colleague.
Qualifications
Education and Experience:
•Bachelor's degree in Life Sciences or Nursing; Bachelor's degree in Nursing is strongly preferred.
•2-3 years medical/clinical experience or clinical/safety experience
•1 year SAE processing experience/or clinical safety experience
•In some cases, other appropriate education and professional training (ie: 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 to perform the job
Knowledge, Skills and Abilities:
•Competent in the use of Microsoft Word, Excel and PowerPoint
•Safety database skills
•Good oral and written communication skills
•Strong attention to detail
•Ability to work within a team or independently as required
•Good knowledge of applicable SOPs, ICH GCP and awareness of PVG 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
PPD is an Equal Opportunity Employer
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Please Note: Applications to this vacancy are not made using our website. When you click above, you will be taken to the recruiter's website to complete your application.
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