IQVIA Biotech is seeking Clinical Sr. Safety Specialist and Clinical Safety Specialist based in the U.S. (Home-Based). Must have at least 2 years of clinical case processing experience and have worked in Argus:

BASIC FUNCTION:

Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.

Primary responsibilities include processing and reporting of incoming safety events and related data.

Serves in a mentorship/leadership role, including Safety Management Lead on moderate to large sized studies/programs that are moderate to complex in scope of work.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Performs safety case processing tasks including, but not limited to:
  • Intake and triage tasks as applicable for assigned projects
  • Reviewing incoming safety information for completeness and accuracy
  • Tracking and data entry
  • Writing clinical narratives
  • Generating queries
  • Follow up with sites for missing and/or unclear information
  • QC of cases and provide feedback as appropriate
  • Generating regulatory reports
  • Reconciliation
  • Generating metrics

• Serve as Safety Management lead on moderate to large sized studies/programs that are moderate to complex in scope of work with minimal guidance. Responsibilities include, but are not limited to:
  • All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.
  • Attendance at team and client meetings
  • Investigator's meeting attendance, if applicable
  • Presentations
  • Training and mentoring of staff on safety processes
  • Compliance with budget, including estimating monthly budget projections

• Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager
• May assist with bid defenses or other presentations
• May mentor and/or train new Safety Management staff
• Point of contact for queries from client or internal stake holders
• Performs other related duties as assigned or requested by department management

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrates expertise in clinical trial safety, including proficiency in leading complex studies and processing complex safety information.
• Requires minimal oversight and guidance from Safety Management Manager.
• Able to independently identify, analyze and problem solve complex issues and trends.
• Provides mentorship to other Safety Management staff, sharing knowledge and expertise.
• Excellent knowledge of clinical research process and medical terminology.
• Excellent written and verbal communication skills. Able to express complex ideas.
• Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute PVG department activities.
• Able to develop knowledge of the disease under study. Able to discuss simpler aspects of the disease process with site personnel and colleagues.
• Able to develop knowledge of protocol, regulatory requirements and company SOPs. Familiar with matrix team structure and phases of research. Able to identify and document regulatory non-compliance and any issues involving subject safety.
• Excellent organizational and interpersonal skills.
• Ability to reason independently to assess and recommend specific solutions in a clinical setting.
• Attention to detail. Able to identify and resolve discrepancies on SAE reports and case report forms.
• Understands electronic data capture including basic data processing functions.
• Understands current ICH/ GCP guidelines applicable to the conduct of clinical research.
• Demonstrates professionalism and presents a positive image of the company.
• Demonstrates excellence in customer service.
• Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
• Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
• Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
• Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
• Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
• Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
• Able to work independently, identify issues and solutions proactively with minimal oversight and input from Safety Management.
• Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very limited physical effort required to perform normal job duties
• Ability to travel domestically and internationally

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
• Minimum of 5 years of experience in clinical trial safety.
• Equivalent combination of relevant education and experience.
• Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required
• Knowledge of electronic data capture required.
• Excellent verbal and written communication skills required.
• Excellent interpersonal and organizational skills required.
• Ability to work independently, prioritize effectively and work in a matrix team environment required.
• Ability and willingness to travel domestically and internationally as required; ability to rent automobile.

LI-SCARBONARA

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status