PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients
Post: Safety Specialist (New Delhi)-114688
Job Description:
Duties and Responsibilities:
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Coordinate serious adverse event (SAE) processes and database activities
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Develop an understanding of budgets and forecasts for assigned projects
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Familiar with and understand PPD SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues.
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Effectively interface with project teams, the client company and investigators regarding SAE activities.
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Prepare for and attend audits, kick-off and investigator meetings. Demonstrate the ability to prioritize and organize workload
Candidate Profile:
Qualifications:
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Bachelor's degree in Life Sciences or Nursing
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Minimum 2-3 years medical/clinical experience or clinical/safety experience and minimum 1 year SAE processing experience/or clinical safety experience
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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 on Next Page...
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Skills and Knowledge:
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Competent in the use of Microsoft Word, Excel and PowerPoint
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Safety database skills
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Good knowledge of applicable SOPs, ICH GCP and awareness of pharmacovigilance regulations
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Ability to review SAE data for completeness and prepare patient narratives from appropriate documentation
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Competent at administrative tasks and project administration activities
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General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required to process SAEs
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Good oral and written communication skills and ability to work within a team or independently as required
Additional Information:
Exp: 2-3 yrs
Location: Delhi
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, IT
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