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: Manager Drug Safety
Job Description
As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
*Travel (up to approximately 15%) domestic and/or international as applicable
*Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
*Keep management appraised of any potential/actual study or staffing issues and develop solutions for same
*Develop and implement department training
*Assist in training of other departments, as requested
*Maintain quality review metrics and attend project quality meetings, as required
Assist with maintenance of project budgets and oversight by identifying out of scope activities
*Assist upper management with resourcing and business development activities
*Attend bid defence meetings, as requested
*Manage small to mid-size drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
*Ensure audit readiness and/or MSS representation at audits
*Develop safety plans, study specific procedures, and workflows for clients, as requested
*Actively identify options for process improvement
*Supervise maintenance of project drug safety files as regionally applicable
Coordinate any committee activities as applicable under supervision
Perform other activities as identified and requested by management
Supervision:
*Manage MSS projects in accordance with established timelines , budget, quality standards and/or contractual requirements
*Develop supporting staff skills, encourage growth and provide regular performance feedback
*Provide project and/or line management of assigned Drug Safety and Administrative staff
*Serve as a mentor and role model for Drug Safety staff.
Requirements
A minimum of 4 years of relevant clinical research I pharmaceutical industry experience, preferably with at least 2 years experience in pharmacovigilance I drug safety .
Advanced proven relevant clinical research I pharmaceutical industry experience, preferably in pharmacovigilance I drug safety.
Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors , or Sponsors
Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other staff
Thorough knowledge of global safety processes and regulations
Good knowledge of medical terminology and coding systems
Very good computer skills
Excellent organizational skills
Excellent communication skills
Very good presentation skills
Very good ability to mentor staff
Ability to work independently or lead study teams
Ability to self-start and show initiative
Detail oriented
Fluent in written and verbal English
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Drivers license.
Additional Information:
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Reference: 042547
End Date: 20th September, 2016
APPLY THROUGH RECRUITERS PORTAL>>
See All ICON Jobs B.Pharm Alerts B.Sc Alerts Chennai Alerts
See All Other Jobs in our Database
.png)
