Ref #: 28374

Employment type: Permanent - Full-Time

Location: Seoul, South Korea

Posted: 26-Apr-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Clinical Research Associate to work closely with our client, a leading pharmaceutical company.

Overview
The PMS is responsible for the timely reporting and processing of respective Serious Adverse Events (SAE), Adverse Event (AE) Serious and non-Serious Adverse Drug Reaction (SADR) and other medically related project information within agreed timelines to Health Authorities and other Key Stakeholders. They are responsible for document archiving, data tracking communication of respective safety reports in compliance with company’s and relevant regulator’s requirements.


Key responsibilities
The responsibilities of the PMS may include, but are not limited to:
- Perform initial review of the adverse event perform seriousness and relatedness assessment and follow up SAE/AE/ADR/SADR queries to investigator sites or reporters
- Liaise with the investigational site and or reporter regarding safety issue
- Ensure accurate entry of safety data into the safety database or relevant system
- May assist the team in create patient adverse event narratives (if appropriate)
- Archive document related to entered safety data and other in accordance with regulatory requirement, respective SOPs and manuals
- Communicate with relevant stakeholder (Health Authority, Site Staff) to clarify enquiry of entered data on the safety database
- May assist the Medical team to train member from other department on how to collect safety information for Spontaneous safety reporting of marketed product to the company
- Assist the team member with safety case monitoring/ Screening activity on safety database
- May attend the project team meeting and teleconference as needed

Required experience and qualifications
- Computer literacy desirable
- Good oral and written communication skills
- Bachelor degree, or local equivalent, in medicine, science or related discipline


Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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