Senior Drug Safety Associate

Senior Drug Safety Associate

Seoul, Korea

ICON plc, a leading global Contract Research Organisation (NASDAQ listed) employing 13,500 people in 40 countries, seeks an experienced pharmacovigilance professional with expertise in managing client relationships and projects along with the know-how of mentoring a team. 

Role Overview;
• Document and Process Serious Adverse Events, Spontaneously reported adverse events and other medically related information per study specific procedures.

• Provide input for and review relevant safety tracking systems for accuracy and quality.

• Perform safety review of clinical data(case report forms) and patient labs

• Prepare, perform quality checks of, and submit expedited to the Competent Authority in South Korea using Ezdrug (South Korea Online Portal).

• Prepare and perform quality checks of global pharmacovigilance intelligence requirements.

• Serve as safety reporting lead for multiple smaller projects and/or pharmacovigilance intelligence lead for pharmacovigilance intelligence stand-alone projects.

• Ensure all ICON and/or Sponsor time frames are met for the reporting of safety information and for the release of global pharmacovigilance intelligence requirements.

• Assist Medical Monitor with documentation and processing routine exception and re-screen approvals.

• Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

• Assist with safety related training for extra-departmental ICON staff as required.

To perform this job successfully, you will need;
•minimum of 2 years of regulatory or pharmacovigilance experience, or other equivalent clinical or pharmaceutical experience required.

• Bachelor’s degree or local equivalent in pharmaceutical, nursing or science

• Good computer skills (Microsoft Word, Excel, Outlook, Access) and safety database familiarity

• Excellent written and verbal communication skills

• Strong identification with ICON’s values

• Attention to details

• Fluent in written and verbal English

• Be able to work independently and as a part of the team

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes.  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 invite you to review our opportunities at www.iconplc.com/careers .