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Company

ClinChoice · 7 hours ago

Pharmacovigilance (PV) Literature Monitoring Consultant

United States

Contract

Remote

Mid, Senior Level

5+ years exp

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BiotechnologyConsulting

Hiring Manager

Pamela Biswas

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Responsibilities

Performs screening, abstracting, indexing, and editing functions

Monitors the quality, accuracy, and timeliness of biomedical literature screening, adverse event reporting, abstracting, and indexing

Assists with the acquisition and, where applicable, translation of published biomedical literature, including conference abstracts

Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing policies and procedures

Ensures comprehensive creation, maintenance, and communication of all standard operating procedures (SOPs), guidelines, and job aids related to these functions

Assists with the training of screeners/abstractors/indexers, and internal team members

Assists with end-user training and request fulfillment

Participates in the management of published literature and conference abstract acquisition and translation

Liaises with regulatory groups to ensure search request results meet current regulatory requirements

Collaborates with pharmacovigilance teams to meet current literature-related adverse event monitoring requirements, including collaboration with ex-US PV groups to develop of journal lists for adverse event screening

Assists in the evaluation of proposals and developments sponsored by intra-company information or systems units for applicability to the specific information needs of Clinical Literature Information Center (CLIC) end-users

Collaborates with internal and external organizations in the development and integration of literature-related systems and information

Maintains personal awareness of developments in the fields of medical information, regulatory policy, adverse event reporting, information storage and retrieval, and information services

Participates in the collaboration with our Company's IT to maintain the Company Product Literature Database to ensure the maximum performance, reliability, data integrity, security, copyright compliance, and precision and recall of the database. Leads end-user and system application development

Participates in data processing, harmonization, deduplication, and standardization activities

Participates in the development, maintenance, and control activities of CLIC terminology to ensure optimal precision and recall of CLIC data

Qualification

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PharmacovigilanceBiomedical literatureInformation storage systemsRegulatory reportingAdverse event reportingForeign language proficiencyAuditsInspectionsBiomedical literature sourcesCommercial biomedical databasesCopyright complianceSemantic technologiesNatural Language ProcessingMachine LearningArtificial IntelligenceSystem Development Lifecycle

Required

Degree in life sciences, information science, pharmacy, or related scientific discipline plus literature-related regulatory reporting

Bachelor’s and 5+ years

3+ years of work with biomedical literature and pharmacovigilance activities

Basic working knowledge of biomedical literature and information storage and retrieval systems

An understanding of US and ex-US pharmaceutical regulations

Good writing skills

Attention to detail

Good time management skills

Foreign language proficiency is desirable

Working knowledge of information storage and retrieval systems

Preferred

Experience with audits and inspections

Knowledge of biomedical literature sources, content, and indexing

Knowledge of commercial biomedical database structure, content, and content search/retrieval

Familiarity with copyright compliance

Familiarity with the application of semantic technologies, Natural Language Processing (NLP), Machine Learning (ML) or Artificial Intelligence (AI)

Experience with the SDLC (system development lifecycle)

Company

ClinChoice

Glassdoor

3.7

ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.

Founded in 1995

Shanghai, Shanghai, CHN

1,001-5,000 employees