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Drug Safety Manager – Safety Reporting Group SRG

The purpose of this role is ensuring expedited and periodic safety reporting compliance. The position covers a broad spectrum of safety reporting activities globally and leadership to the safety reporting team in Europe and South America.

Role Responsibilities

Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
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 scopeactivities
Assist upper management with resourcing and business development activities
meetings, as requested
Manage small to midsize 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
Manage REG GRA projects in accordance with established timelines , budget, quality standards and/or contractual requirement
Develop supporting staff skills, encourage growth and provide regular performance feedback
Provide project and/or line management of assigned REG staff
Serve as a mentor and role model for REG staff.

Requirements

· A minimum of 4 years of relevant clinical research I pharmaceuticalindustry experience, preferably with at least 2 years experience in pharmacovigilance I drug safety.

· Ability to interact effectively and professionally with various levels ofstaff 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 totravel. Therefore, dependent on the employee's location, the employeemay be required to possess a valid Drivers license.

· Medical/science background (nursing preferred) and/or bachelors degree or localequivalent

About ICON

We are a company of 13,500 employees in eighty global locations. We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster in a more cost-effective way with better patient outcomes. We are a top five organization with solid earnings and growth potential. Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve. As a company we strive to exceed our customers’ expectations in drug development solutions

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Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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Safety Reporting Manager

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About the role

This vacancy has now expired. Please see similar roles below...

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