Pharmacovigilance Scientist I
Company: Planet Pharma
Location: Basking Ridge
Posted on: June 23, 2022
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Job Description:
The PV Scientist Pharmacovigilances main role is to process and
evaluate adverse events (AEs) received from clinical trials and/or
postmarketing sources to support drug development and ensure safety
and efficacy of company products. This includes SAE reconciliation,
quality check (QC), data collection, entry, evaluation, follow up,
and distribution in a timely fashion to ensure compliance with
local and global regulatory reporting.Delivers high quality work,
assesses individual and vendor/CRO work with minimal supervision.
Executes strategic plans within multiple projects and can
prioritize in accordance with strategy. Competent in identifying
and understanding issues independently and can contribute to
remediation plans Competent knowledge of pharmacology, clinical
research and medical terminology, global data entry conventions and
systems and procedures for application in daily work. Communicates
effectively with team/project members using clear and effective
verbal and written communication skills Effectively manages own
workload to meet multiple deadlines in a timely manner. Understands
functional role and others' functional roles within the clinical
trial process.
Requirements:Bachelor's degree in nursing, pharmacy, or healthcare
related field with minimum of two (2) years of PV experience and
knowledge of FDA regulations.
Keywords: Planet Pharma, Newark , Pharmacovigilance Scientist I, Other , Basking Ridge, New Jersey
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