Drug Safety Manager Icon Clinical Research-Chennai, .."R"

Drug Safety Manager
Icon Clinical Research India Private Limited - Chennai, Tamil Nadu

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance. As a Manager, the employee is expected to recognize the importance of and create a culture ofprocess 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.
• 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)
• A minimum of 8 years of relevant clinical research / pharmaceutical industry experience, preferably with at least 6 years experience in pharmacovigilance / 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 EnglishCLICK HERE TO VIEW/ APPLY