Literature Review Professional

Job Overview

We are seeking a highly skilled Literature Review Professional to join our Research and Development function. In this role, you will be responsible for conducting literature searches, summarizing adverse events, and providing support to internal stakeholders.

Key Responsibilities:

• Conduct routine and on-demand literature search activities, refining search strategies to enhance the relevance and quality of retrieved publications.
• Provide concise summaries of reported adverse events and complaint records to aid in regulatory and clinical decision-making.
• Lead direct reports, ensuring quality efficient stakeholder management and compliance with policies and procedures.
• Liaise with vendors and publishers to resolve technical issues and communicate service-impacting changes across the organization.
• Manage acquisition and analysis of usage data to inform journal selection and subscription decisions.
• Retrieve full-text articles for Reprints Desk bounce backs to ensure uninterrupted access to requested literature.
• Develop and deliver training tutorials and sessions to support end-user proficiency with knowledge center tools and resources.
• Provide required usage reporting to the Copyright Clearance Center to ensure compliance with licensing agreements.
• Respond to inquiries received through the Ask AKC mailbox, offering timely and accurate support to internal stakeholders.
• Oversee daily operations, support professional development, and foster a collaborative high-performance work environment.
• Develop and execute targeted literature search strategies based on clinical protocols, product names, and other relevant criteria to support a range of functions, including Clinical Evaluation Reports (CERs), State of the Art (SotA) reviews, and Safety and Performance assessments.
• Conduct annual queries for both clinical and nonclinical reports in collaboration with Regulatory Affairs.
• Provide literature support for Medical Safety and Complaint Intake, as well as ad-hoc search requests from departments such as Medical Information and Health Economics and Outcomes Research (HEOR).
• Perform summarization analysis to identify any new complaints, risks identified in publications, and add to appropriate systems.
• Execute process activities in accordance with established Standard Operating Procedures (SOPs).
• Maintain a strong understanding of data requirements for technical and adverse event complaints to ensure compliance.
• Collaborate effectively across global time zones to support international operations.
• Review data entry and follow-up documentation for accuracy, completeness, and timeliness.

To be successful in this role, you will need:

• Bachelor's degree in science or healthcare field.
• 3-5 years relevant work experience in device, drug safety, compliance, quality assurance, or data analytics, including managing direct reports.
• Experience communicating with US-based customers.
• Experience in Medical Device, Pharma Complaint Handling, Device Vigilance, Pharmacovigilance.
• Proven strong leadership skills and ability to interact with and influence senior leadership.
• Excellent listening ability and communication skills.
• Excellent decision-making, troubleshooting, and negotiation skills.
• Ability to manage multiple tasks, attention to detail, prioritize work, and manage time well.
• Knowledge and understanding of national and international medical device regulations and regulatory guidelines.
• Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice.
• Basic knowledge of MS Office.
• Excellent written and verbal communication skills.