Senior Director, Medical Safety Services (US-Remote!!)

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

This position can be remote- or office-based in the United States.

Who are you?

You are an experienced drug safety leader who has led pharmacovigilance teams providing services such as SAE/ADR management, literature searches and periodic safety report submissions. You also have experience in investigation of safety issues and safety consulting on processes, tools, and regulatory requirements related managing the safety of drugs, vaccines, and devices throughout the life-cycle of a product.

What will you be doing?

Directs the strategic and operational functions of the Drug Safety team to meet project objectives with SAE/ADR management, periodic safety reports, investigation of safety issues, safety consulting on processes, tools, and regulatory requirements related to managing the safety of drugs, vaccines, and devices.

Supports the implementation of processes, systems and tools to improve efficiencies in company services.

Participates in developing new and existing business by attending sales presentations.

Ensures appropriate employee resources are available to meet corporate and project objectives.

Ensures that project staff fulfills their responsibilities in accordance with company policies, procedures, and SOPs.

Responsible for the training and career development of staff to ensure optimal performance and compliance with company systems and processes

Creates an environment that encourages learning, self-improvement, and career development for staff.

Maintains familiarity with current industry practices and regulatory requirements that affect SAE/ADR management and reporting of individual and periodic safety data.

What do you need to have?

• An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences or a health-related field or equivalent degree

• Broad and in-depth contract research organization and pharmaceutical experience including project leadership and management of technical staff required

• Minimum of 8 years of experience in pharmacovigilance or related services and at least 8 years in a managerial role.

• Advanced skills with industry-standard safety systems

• Experience preparing, implementing, and managing department operating plans, budgets, and profitability required

• Track record of implementing processes that assure compliance with regulatory submissions requirements for human drugs, biologics, and/or devices required

• Proven history of successful interaction with internal and external customers, required

• Effective written and oral communication and presentation skills, required

• Reads, writes, and speaks English; fluent in host country language, required

• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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