Medical Director 1

Employer
ICON Strategic Solutions - EMEA
Location
United Kingdom, Homeworking
Salary
Competitive
Start date
23 Jan 2023
Closing date
22 Feb 2023

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Global Medical Safety Lead, homebased in the UK or other EMEA countries / Permanent

The Global Medical Safety Lead will be leading and performing the assessment of medical safety data, develop safety signaling and benefit-risk management strategies as well as collaborate with both internal and external internal teams.

Why Join?

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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, colour, 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.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Roles and Responsibilities
  • Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
  • Perform safety signal management and benefit risk assessment activities
  • Lead cross-functional teams to perform regular review of existing and emerging aggregate safety data for assigned product(s)
  • Contribute to the development of the overall safety governance structure and activities
  • Provide safety strategies and deliver accurate, timely and high-quality safety contributions for the preparation of relevant sections of regulatory submission documents globally
  • Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
  • Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
  • Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
  • Oversee the medical assessment of individual case safety reports
  • Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues)
  • Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board
  • Provide medical safety contributions at internal audits and regulatory inspections
  • Support the development of and updates to GPS Standard Operating Procedures and other controlled documents (e.g. work instructions, forms, templates)
  • Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
  • Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners
  • Participate in cross-functional teams and initiatives


What is required

  • MD degree or equivalent required
  • Ideally, a minimum of 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
  • Ideally, a minimum of 1 year of experience in clinical practice or in academic medicine
  • Strong scientific and analytic skills
  • Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
  • Demonstrated ability to perform medical assessments of safety data from multiple sources
  • Experience with authoring complex documents and contributing to regulatory submissions
  • Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
  • Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
  • Excellent presentation skills with the ability to communicate complex issues clearly
  • Relevant computer skills, including proficiency with Microsoft Office
  • Fluency in written and spoken English
  • Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
  • Demonstrated ability to perform medical assessments of safety data from multiple sources
  • Experience with authoring complex documents and contributing to regulatory submissions
  • Knowledge of adverse event reporting systems
  • Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.


What is offered
  • Full-time and permanent contract of employment with us seconded to one single sponsor
  • The role is NOT open to Freelancers/Freelance Contractors
  • The role is homebased in the UK/England
  • The role could also be homebased either in Germany, Spain or Poland for the right candidate
  • Salary according to level of skills and experience
  • Company benefits and annual leave


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.

Company

ICON is the leading provider of Functional Service Provision (FSP) globally. Our team of operational, functional and therapeutic specialists offer a range of FSP models that can be customised to deliver the most efficient operating model for your organisation. We bring a suite of capabilities, expertise and technology to augment your operations, increase R&D efficiencies and improve site engagement to access patient populations and deliver timelines and milestones. We have deployed FSP solutions across all major functions from clinical monitoring and project management through data management, statistical programming and beyond.

 

ICON FSP experience

  • 90+ FSP partnerships
  • 13,000+ Employees
  • 90+ Countries

 

Functional areas

Our offering includes a range of globally scalable FSP solutions that are customised to provide support where and when you need it. We have significant experience in providing bespoke FSP solutions, particularly in:

  • Study start-up
  • Project Management
  • Clinical monitoring
  • Pharmacovigilance / Safety
  • Clinical Supplies Management
  • Data management

Biostatistics and programming

Contracts management

  • Investigator payments
  • Clinical vendor management & category management
  • Medical writing
  • Medical affairs
  • Regulatory affairs
  • Regulatory publishing
Find Us
Website
Location
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
United Kingdom
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