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Clinical Safety Associate- Vaf

2 weeks ago

Remote, India ProductLife Group Full time

ProductLife Group is looking for a Clinical Safety associate to join our dynamic team to contribute to the activities performed in the Hub:
**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