Senior Drug Safety Associate
About the role
This vacancy has now expired. Please see similar roles below...
Senior Drug Safety Associate
Location: Warsaw, Poland
ICON Plc, a leading global Contract Research Organisation (NASDAQ listed) employing 13,500 people in 37 countries, is looking to hire a Senior Drug Safety Associate to join the team in our Warsaw offices.
The Role:
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 10%) domestic and/or international. Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
- Prepare and perform quality check of regulatory documentation packets, and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and third parties.
- Ensure compliance with regulatory reporting requirements for safety reporting (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
- Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors.
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files. Liaise with Sponsors, ICON project managers, investigational sites, Competent Authorities, local notified bodies and third parties as necessary
- Attend project team meetings and teleconferences as required.
- Maintain the projects regulatory submission files are in inspection ready state at all times. Prepares for, and attends audits and inspections.
- Facilitate and respond to company, client and regulatory audits where required.
- Delivers presentations to internal and external customers as required.
- Holds the training for GRA project team, Investigators and other departments on regulatory reporting activities. Generation of project specific procedures.
- Act as safety reporting lead for multiple projects providing management/project management support.
- Actively identify out of scope activities.
- Train/mentor Drug Safety Associate staff.
- Participate in interdepartmental activities and assist management with weekly and monthly project status reports including quality review findings and metrics.
- Alert Line Manager to any quality or timeline issues.
- Shares of ideas and suggestions with team members ensuring effective communication.
- Perform other activities as identified and requested by management
Role Requirements:
- The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
- Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
- Medical/science background and/or bachelor’s degree or local equivalent.
Benefits of Working in ICON
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.
We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.
This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as 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.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You will be joining a progra
Reference
2024-110000
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Study Start Up
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
The Study Start-Up Associate (SSUA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in
Reference
2024-109930
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Bulgaria, Sofia
Location
Sofia
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
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
JR117777
Expiry date
01/01/0001
Author
Moushami RoyAuthor
Moushami RoySalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Operations
Job Type
Permanent
Description
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, biotech
Reference
JR117460
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth DaviesSalary
Location
Mexico, Benito Juarez (PRA)
Department
Clinical Monitoring
Real World Solutions
Location
Bogota
Mexico City
Lima
Benito Juarez
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
Site Management Associate II - (SMA II) Office Based role (Flex)Mexico City, MexicoLima, PerúBogotá, ColombiaICON plc is a world-leading healthcare intelligence and clinical research organisation. Fro
Reference
JR118239
Expiry date
01/01/0001
Author
Olivia MolinaAuthor
Olivia MolinaSalary
Location
Limerick
Department
Clinical Operations Roles
Location
Limerick
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109966
Expiry date
01/01/0001
Author
Rajvir SamraAuthor
Rajvir Samra