Drug Safety Manager

If you are a strong people and project leader who has experience with drug safety / pharmacovigilance, we want to hear from you.  Our Drug Safety Manager will lead a team of people onsite at our Mexico City office as well as be responsible for study management.  As a line manager you would work to develop employees, manage interpersonal issues, oversee workload, conduct performance reviews, set training agendas, and ensure that activity targets are met.  As a project manager you should be deft with invoicing, out of scope work, change orders, the ability to manage several drug safety projects at once, and ensure that the overall client relationship runs smoothly.   To qualify you must have relevant industry experience, be legally authorized to work in Mexico without restrictions, as well as speaking and writing fluently in English.  This is an office based role reporting to our Mexico City office.

Overview of the Role

This role ensures that projects within Medical and Safety run efficiently, accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors, ensures the daily project operations of assigned safety projects, provides project management on Drug Safety projects, and oversees Drug Safety and Administrative staff. 

Responsibilities of the Role

·         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 managementManage 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.

Role Requirements

·         A minimum of 4 years of relevant clinical research / pharmaceutical industry experience, preferably with at least 2 years’ experience in pharmacovigilance / drug safety.

·         Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent

·         Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors

·         Demonstration of professional demeanor, 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

Increasing competition and regulatory demands are putting more and more pressure on pharmaceutical companies and medical device manufacturers to reduce the product development timelines.  You can be part of the solution to drive efficiency and improve results for our partners and ultimately for the population the investigational product may eventually serve.  We are a company of 13,500 employees in forty countries globally.  We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster and in a more cost-effective way to foster better patient outcomes.  We are a top five clinical research 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. 

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent retirement plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.  We care about our people, since they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.  Caring for patients while enjoying what we do and delivering great results is something we can achieve if we know we can count on each other and have a clear vision of where we want to go.

ICON is an equal opportunity employer – Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.