Clinical Literature Monitoring Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Sr . Specialist Clinical Literature Monitoring Consultant (Remote) to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Position Description: Sr . Specialist Clinical Literature Monitoring

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.  Performs screening abstracting indexing and other project work as needed. Plans organizes trains monitors coordinates and evaluates the work of screening/abstracting/indexing workload 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.   Engages stakeholders and supports their requests.

Main Job Tasks and 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

Education and Experience:

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 (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:

• 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)

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step. Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific .

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice Canada Inc. is proud to be an equal opportunity employer valuing and respecting diversity.  We are committed to inclusive barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act in all aspects of the hiring process upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ('PIPEDA')  personal information is collected under the authority of the Act and will only be used for candidate selection.