南京招聘

J O B F U N C T I O N S / R E S P O N S I B I L I T I E S

The responsibilities of the Senior/Drug Safety Associate 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 reporter(s)

? 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.

? May assist the team member with safety case monitoring/ Screening activity on safety database.

? May attend the project team meeting and teleconference as needed.

QUALIFICATIONS

? BA/BS/BSc or qualified nurse (RN);

? Medical / Science background with relevant clinical experience

? Knowledge of medical Terminology

? Excellent communication skill

EXPERIENCE & SKILLS

? Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.