Covance

Assoc I PSS

Job Location(s) PH-Manila
Job Number
2021-67647
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time
Telecommute
No

Job Overview

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 follow-up, report preparation and
submission to regulatory authorities
- Guide Junior Safety Data Analyst (Voice) in managing voice calls (asrequired)
- 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

Education/Qualifications

Bachelor’s or Masters in Pharmacy or Life Science or Medical Science or related area
- Min. 2 years of experience in Pharmacovigilance

Experience

Voice call management
- Pharmacovigilance
- Clinical Research
- Good understanding of regulatory requirements, good Pharmacovigilance practices
and ICH-GCP guidelines
- Technical proficiency with Microsoft Office suite applications
Key Competencies
- Ability to receive and manage in-bound and out-bound calls
- Attention to detail
- Good verbal and written communication skills
- Concern for quality
- Analytical capabilities
- Ability to analyze & synthesize medical information
- Customer focus

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