job title: clinical safety associate(plg)

Responsibilities:

• Processing of Adverse Events (AEs) / Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), and other immediately reportable events in the safety database including relevant communication with Customer

• Query preparation, sending and follow-up

• Maintenance of study trackers and other relevant tools

• Reconciliation of clinical safety information/activities with Customer/CRO/Data Management

• Assisting in aggregate periodic safety reports preparation

• Assisting in expedited and periodic safety reports submissions

Education and Experience:

• BSc or equivalent in Life Science discipline or PharmD

• Experience in Pharmacovigilance/Drug Safety Data Entry

• Knowledge of databases (Safety database: SafetyEasy)

• Knowledge of drugs and pharmaceutical environment

• Knowledge of Pharmacovigilance/Drug Safety regulation (national and international) and Pharmacovigilance tools

• Demonstrable case management experience

Skills:

• Adaptability

• Analytical skills

• Flexibility

• Reliable

• Good writing skills

• Adept in using MS Office tools and Pharmacovigilance tools