Opportunity for Safety Administrator in PPD Pharmaceuticals
Post: Safety Administrator - II
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Job 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.
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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.
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Candidate Profile:
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.
Additional Information:
Experience: 2-3 years
Location: Haryana-New Delhi
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 30th Sep., 2012
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