Assoc Ii Pss - Pune, India - Labcorp

Labcorp

Verified Company

Pune, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures

Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service Operational
Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case followup, report preparation and submission to regulatory authorities
Guide Junior Safety Data Analyst (Voice) in managing voice calls (as required)
Perform any other support activities as assigned tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search
Assume responsibility for quality of data processed

Voice call management

Pharmacovigilance
Clinical Research
Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH-GCP guidelines

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