JUMP TO CONTENT

Senior Safety Scientist

  1. United States
2025-118144
  1. ICON Strategic Solutions
  2. Regulatory Affairs
  3. Remote

About the role

This vacancy has now expired. Please click here to view live vacancies.

Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to high in complexity or which concern low to high complexity products. Additionally supports activities including generation, review, and presentation of aggregate safety data, mentoring of more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.


  • Serves as a creator/contributor for signal detection and product safety scientist tasks.
  • Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.
  • Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
  • Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)
  • Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.
  • Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.
  • Prepare data for and actively participate in safety governance processes.
  • As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator’s Brochure (IB), or Informed Consent Form (ICF)
  • Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity, or which concern low to high complexity products.
  • Advises clients on safety related issues.
  • Supports training and mentoring of junior colleagues.
  • Contributes to development of processes, tools and systems.
  • Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.
  • Participates in departmental initiatives; Serves as a subject matter expert in designated area.
  • Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Frequent contacts with internal personnel and outside customer representatives.

  • Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences fields.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
  • 10 + years Pharmacovigilance experience
  • Extensive signal detection and /safety risk management experience
  • Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
  • Extensive signal detection & management experience is a must.
  • Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
  • Working knowledge of MedDRA
  • Excellent attention to detail, data interpretation and medical-scientific writing skills
  • Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately Solid project management skills with the ability to manage multiple projects simultaneously and ability to redress issues proactively with limited management intervention
  • Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise
  • Excellent oral and written English language communication skills, including paraphrasing skills
  • Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
  • Working knowledge of Oracle Empirica.
  • Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience
  • Ability to work effectively within a team to attain a shared goal

 

What ICON can offer you:

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others



Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
Vaccination vial
The Role of Regulatory Affairs in Clinical Research

Teaser label

Industry

Content type

Blogs

Publish date

01/18/2024

Summary

Introduction to Regulatory Affairs in Clinical Research Regulatory affairs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. In the

Teaser label

Explore the pivotal role of regulatory affairs in clinical research with our insightful blog.

Read more
View all

Similar jobs at ICON

TMF Lead

Salary

Location

Poland, Warsaw

Department

Clinical Trial Management

Location

Warsaw

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Document Management

Job Type

Permanent

Description

We are currently seeking a TMF Lead to join our diverse and dynamic team. As a TMF Lead at ICON, you will be responsible for overseeing the Trial Master File (TMF) management processes, ensuring compl

Reference

JR128995

Expiry date

01/01/0001

Magda Kozuszek Read more Shortlist Save this role
Senior Global Regulatory Affairs Specialist

Salary

Location

South Africa, Johannesburg

Department

Full Service - Regulatory

Location

Sofia

Warsaw

Johannesburg

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

Description

We are currently seeking a Senior Global Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Global Regulatory Affairs Specialist at ICON, you will play a pivotal role in d

Reference

JR129102

Expiry date

01/01/0001

Caroline Lock

Author

Caroline Lock
Read more Shortlist Save this role
TMF Lead

Salary

Location

Mexico, Mexico City

Department

Full Service - Clinical Operations

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Document Management

Job Type

Permanent

Description

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 I

Reference

JR128582

Expiry date

01/01/0001

Ana Lucia

Author

Ana Lucia
Ana Lucia

Author

Ana Lucia
Read more Shortlist Save this role
TMF Specialist I

Salary

Location

Poland, Warsaw

Department

Clinical Trial Management

Location

Warsaw

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Document Management

Job Type

Permanent

Description

We are currently seeking a TMF Specialist I to join our diverse and dynamic team. As a TMF Specialist I at ICON, you will play a vital role in becoming familiar with Trial Master File (TMF) documentat

Reference

JR128996

Expiry date

01/01/0001

Magda Kozuszek Read more Shortlist Save this role
Regulatory Project Manager

Salary

Location

Belgium, United Kingdom, Netherlands, Europe

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Any EMEA Location

Belgium

Netherlands

UK

Remote Working

Remote

Area of interest

Europe ICON Full Service & Corporate Support Talent Acquisition

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Regulatory Project Manager - Homebased in UK/Europe As a Regulatory Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare i

Reference

2025-117443

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Senior Manager, Regulatory Strategy

Salary

Location

Mexico

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Mexico

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

 We are currently seeking a Senior Manager, Regulatory Strategy to join our diverse and dynamic team. As a Senior Manager, Regulatory Strategy at ICON, you will play a pivotal role in designing and an

Reference

2025-118624

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above