Associate Medical Safety and Data Review Director, Homebased - Iqvia Biotech

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.

BASIC FUNCTIONS:

The medical department consists of the Vice President, Medical; Senior Director, Medical Operations; Senior Directors, Medical; Senior Medical Directors and Medical Directors; Director Medical Safety and Data Review; Medical Data Review Director; Associate Medical Safety Directors; Medical Safety and Data Reviewers; Medical Operation Bidders; and Medical Monitor Operations Specialists. 

Primarily responsible for medical data review and medical safety case processing and related safety activities.  Performs review of medical data to ensure medical/scientific plausibility and to employ medical assessment and knowledge.  Also, provides medical expertise in assigned trials and standalone safety projects.  Train and mentor team members in medical and safety review activities.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

MEDICAL DATA REVIEW (MDR) RESPONSIBILITIES

• Provide medical review of data listings for Adverse Events, concomitant medications, medical history, eligibility criteria, protocol deviations, labs, vitals, ECGs and RECIST criteria, other study specific data, and patient profiles; preparation of periodic summary reports for safety data, Safety Trend Analysis Report (STAR)
• Provide outlier analysis and generate queries for missing/discrepant data through database lock    
• Perform coding review of Serious Adverse Events, medical history, concomitant medication and AE line listings for accuracy and consistency  
• Proficiency in the use of data listings, patient profiles, data analytic platforms, e.g.: Qlik Sense, and various EDCs systems including Medidata RAVE and INFORM
• Prepare periodic MDR summary reports
• Identify anomalies in patient reported data by performing Subject Level Data Review, querying clinical sites to determine accuracy as required
• Provide aggregate review of safety information including medical data, to maintain oversight of the Investigational product’s safety profile. 
• Compose Safety Trend Analysis Report to summarize medical data reviewed and highlight critical findings
• Conduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient data
• Ensure data quality focus to audit readiness with regulatory compliance
• Provide medical review of coded listings, such as adverse events, medical history, concomitant medications or other medical data listings to verify medical accuracy of clinical data
• Define data capture requirements in line with protocol and reporting needs
• Support data analytics by reviewing the visualizations and identify and escalate potential issues of concerns
• Present data at multi-disciplinary internal and/or client meetings as required
• Maintain strong customer relationships
• With guidance, track performance and identify issues requiring remediation and their root causes, and implement remedial actions as required
• Ensure timely follow-up and resolution of compliance issues
• Serve as Subject Matter Expert (SME)
• Serve as Point of Contact/ back-up Point of Contact at program level
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
• Review and contribute to Medical Data Review Plan and summary report
• Attend Kick-Off Meetings, weekly team meetings, and client meetings, as required or requested
• Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures
• Drive the delivery of end-to-end study data quality and integrity
• Perform special projects as requested by management

SAFETY REVIEW RESPONSIBILITIES

• Medical review and case assessment of SAEs including assessment and quality control of coding of preferred term, medical history, indications of concomitant medications and treatment medications; determination of seriousness, causality and expectedness; narrative review; query generation and follow up of SAEs till case closure
• Compose sponsor comment/summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to Safety Management case processing teams on projects being supported
• Provide coding review of AEs, medical history, concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Review and sign off on the Safety Management Plan per medical safety scope agreed in contract
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Provide support to line management in addressing any escalations related to quality of medical safety review or accuracy of medical safety assessment for awarded projects
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Maintain awareness of medical safety regulatory developments in the industry
• With guidance, track performance and identify issues requiring remediation and their root causes, and implement remedial actions as required
• Ensure timely follow-up and resolution of compliance issues
• Serve as Subject Matter Expert (SME)
• Serve as Point of Contact/ Back-up Point of contact at for medical team members or at program level
• Perform special projects as requested by management

SPECIAL PROJECTS:

• May obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc
• Participation in a variety of team quality improvement efforts as necessary
• Training of newcomers

SKILLS, AND ABILITIES:

• Ability to work in partnership with a multidisciplinary group of colleagues
• Outstanding ability to work independently with minimal supervision

• Ability to work effectively within a team and matrix environment, including coworkers, managers and clients

• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
• Excellent oral and written communications skills and interpersonal skills
• Outstanding customer focus skills for internal and external team members
• Attention to detail
• Strong analytical skills and understanding of medical data
• Ability to proactively identify issues of significance
• Working knowledge of medical terminology, pharmacology, anatomy, and physiology
• Medical and operational focus towards metrics and status information, and aptitude to take appropriate actions for appropriate resolution
• Excellent organizational and problem-solving skills
• Ability to work on multiple projects and manage competing priorities
• Ability to plan and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time-based metrics
• Excellent coaching skills
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice

•  Knowledge of clinical trials and pharmaceutical research process

• Ability to establish and meet priorities, deadlines, and objectives
• Ability to show initiative and flexibility with assignments
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• Medical degree from an accredited, internationally recognized medical school
• 5 years’ experience in the practice of medicine in a clinical or academic setting which may include specialty medical training or fellowship
• Minimum of 5 years’ experience in Medical Data Review and Medical Safety Review

PHYSICAL REQUIREMENTS:

• Extensive use of telephone, email, and face-to-face communication requiring accurate perception and elocution of spoken and written English
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• The ability to travel based on client or company needs, <5% of time

#LI-AP22

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.