JUMP TO CONTENT

Strategic Solutions - Regulatory Affairs/ Drug Safety/ Quality Assurance

Regulatory Affairs

At ICON Strategic Solutions, we are experts at helping our clients to navigate through the complexities of global regulatory requirements and emerging issues by supporting with resourcing provisions and ramp-ups of embedded Regulatory professionals.

Strategy Submissions Support

Strategy

employees talking

Having the right strategy is crucial at all stages of the product lifecycle. Whether you’re preparing for your first pre-IND/CTA meeting or approaching patent expiration, we will help you consider all the options so you can take the most strategic stance.

Submissions

employees talking

Doing a submission right the first time can make the difference between being first to market or just another me-too. Whether it is an eCTD to the FDA, an orphan drug application in Europe, or a medical device, our experts will help you get to market quickly and smoothly.

Support

employees talking

We provide temporary on-site support for organizations that find themselves suddenly overloaded. Our extra hands and minds can make things happen fast—and by providing you with regulatory assistance on routine work, our support can help you focus on your top priorities.

ICON has developed strategic partnerships with many of the world’s largest pharma companies - and every partnership evolves with our client's needs and Regulatory compliance. This is evidenced by our capabilities that have led to the approval of 18 of the world’s top 20 best-selling drugs. Regulatory Affairs is a growing group across the industry and we are proud to highlight many career opportunities globally.

employees clapping

Pharmacovigilance & Drug Safety

ICON Strategic Solutions Pharmacovigilance team members bring together all safety services into a seamless and transparent delivery solution, with easy-to-review outputs, a strong focus on continuous quality improvement, and operational efficiency ensuring patient safety. Our client-embedded employees process cases based on an innovative cloud-based system, featuring automated and configurable business rules. This enables them to gain visibility into the safety profile of an investigational product throughout its lifecycle.

We provide a comprehensive range of drug safety services, minimising risk and protecting patient well-being from clinical development to post-marketing. By using versatile technologies, targeted data collection, and reports from multiple sources, our experts support our clients in protecting patients. These services help to detect, assess, understand, quantify, and minimsze the risk of adverse reactions.

Pharmacovigilance is a growing area in the industry and we have many career opportunities available.

Quality Assurance

ICON Strategic Solutions has the resources to meet your requirements for Phase I - IV clinical trials.

In addition to providing in-house Quality Assurance auditing for all clinical trials, the Quality Assurance department provides stand-alone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GMP and GLP regulations. Our QA services encompass the following:

  • Auditing
  • Phase I facilities
  • Phase I - IV GCP audits
  • Clinical laboratories (GCP, GLP)
  • Database and Statistical tables
  • Computer validation
  • Clinical trial reports
  • Pre-FDA/regulatory inspections
  • Quality Systems Development (GCP, GLP)


With QA personnel located across Europe, the US, Asia-Pacific, Latin America and Japan, the ICON QA team is flexible enough to provide individual and personalised career development paths and services for locally managed projects.

employees pointing at a laptop screen


Hear from our Regulatory and Medical Writing team on their career growth at ICON Strategic Solutions.

Press play to find out more

List #1

Roles in this area at ICON

Graduate Pharmacovigilance Associate

Salary

Location

Mexico City

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Mexico City

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

As a Graduate Pharmacovigilance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119534

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
Graduate Pharmacovigilance Associate

Salary

Location

Mexico City

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Mexico City

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

As a Graduate Pharmacovigilance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119408

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
Investigator Payment Associate

Salary

Location

London

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

London

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Accounting & Finance

Job Type

Permanent

Description

Title: Investigator Payment AssociateLocation: London, office based 1 day a weekSponsor dedicated  As a Investigator Payment Associate you will be joining the world’s largest & most comprehensive clin

Reference

2025-119550

Expiry date

01/01/0001

Amani Yousef

Author

Amani Yousef
Read more Shortlist Save this role
eCOA Project Manager

Salary

Location

Poland

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Poland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

As a Digitial Health Solutions Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-118415

Expiry date

01/01/0001

Rajvir Samra

Author

Rajvir Samra
Read more Shortlist Save this role
Global Site Identification and Feasibility Specialist

Salary

Location

Romania, Bulgaria, Czech Republic, Hungary

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Bulgaria

Czech Republic

Hungary

Romania

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

As a Senior Feasibility Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-118795

Expiry date

01/01/0001

Amani Yousef

Author

Amani Yousef
Read more Shortlist Save this role
CTA Submission Manager (IVD)

Salary

Location

Hungary, Poland, Czech Republic, Romania, United Kingdom

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Czech Republic

Hungary

Poland

Romania

UK

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

CTA submission manager (in Vitro Diagnostis Regulations - IVDR) - Homebased in Poland, Hungary, Latvia, Lithuania, Poland OR Romania The Regional/Global CTA Submission Manager (CTA-SM) is accountable

Reference

2025-119367

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
View all
View Jobs

Browse popular job categories below or search all jobs above