Specialist, Clinical Literature Information Scientist

Job Description

Provides pertinent and timely information on our Company’s products and interests from the world’s biomedical literature in support of regulatory, clinical research, marketing, and legal functions.  Plans, organizes, monitors, coordinates, and evaluates the work of vendor screening/abstracting/indexing staff to ensure effective and efficient collection, storage, and dissemination of literature-related information.  Maintains up-to-date awareness in the areas of literature-related copyright compliance, adverse event reporting, and information storage and retrieval systems.  Performs screening, abstracting, indexing, and other project work as time allows.  Engages stakeholders and supports their requests.

Primary activities include, but are not limited to:

• 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 vendor 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

• When necessary, performs ad hoc screening, abstracting, indexing, and editing functions

• 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

Position Qualifications:

Education Minimum Requirement:

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

Required Experience and Skills:

• Minimum of 2 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 (specific knowledge of literature-related adverse event reporting preferred); 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 and Skills:

• 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)

• Experience with audits and inspections, especially those related to pharmacovigilance

NOTICE FOR