To responsible for 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 timeline to Health Authority and other Key Stakeholders.

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

• Senior Drug Safety Associate - min 3 years’ experience as Drug Safety Associate or related Global/Regional experience

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