ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Drug Safety Coordinator - 005168
Job Description:
1. PURPOSE OF THE JOB:
Serve as support to Drug Safety management in all aspects of departmental activities as needed
Serve as technical expert with regard to all aspects of safety monitoring for clinical trials and post-marketing surveillance
Ensure that daily project safety activities are completed in accordance with ICON standards and other applicable standards
Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information
2. JOB FUNCTIONS/RESPONSIBILITIES:
*Provide technical expertise to DSA staff, and lead safety projects as required
*Serve as a resource to staff performing start-up activities for new projects
*Review SSPs, maintain appropriate documentation, and liaise with ICON QA department as necessary prior to management review and approval of SSPs
*Develop, maintain, and document new workflow processes and liaise with external departments, as needed
*Assist Medical Management team with business development activities
*Assist management with regularly scheduled status reports as necessary
*Serve as a resource to Medical Affairs staff with regard to SOPs, SSPs, and other regulations
*Liaise with sponsors, ICON team, and investigational sites on safety issues
*Complete safety project tasks as assigned (may include SAE processing, regulatory reporting, safety review of clinical data, etc.)
*Serve as liaison between Safety, Administrative, and Management staff
*Provide mentorship for less senior DSA staff
*Assist staff in identifying out of scope work
3. QUALIFICATIONS/EXPERIENCE REQUIRED:
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (US)
• Medical/science background (nursing preferred in US) with relevant clinical experience and 3 years (minimum) safety or pharmacovigilance experience, or equivalent
• Thorough knowledge of regional safety processes and regulations
• Ability and willingness to travel 10% or as needed
• Strong computer skills (Microsoft Word, Excel, Outlook, Access)
• Excellent organizational skills
• Excellent communication skills
• Strong presentation skills
• Strong ability to mentor staff
• Fluent in verbal and written English
• Clearly demonstrates professional demeanor, judgement, and discernment in interactions with colleagues, clients and other ICON staff
Additional Information:
Experience: Min.3 years
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Pharmacovigilance
End Date: 17th Aug, 2013
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