Full Job Description
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
IQVIA Biotech is seeking a Senior Safety Specialist (Office/Home-Based):
Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and Novella 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 performed by Clinical Safety Associate and/or Senior Clinical Safety Associate
Reviewing incoming safety information for completeness and accuracy
Tracking and data entry
Writing clinical narratives
Contacting sites for missing and/or unclear information
QC of cases
Generating regulatory reports
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
Training 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
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 and leadership 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 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 3 years of experience in clinical trial safety.
Equivalent combination of relevant education and experience.
Computer literacy and experience working with Microsoft Office (Word, Excel) required
Knowledge of electronic data capture preferred.
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.
This position is classified as exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.