Safety Specialist (Device) - IQVIA Biotech (US or Mexico - Homebased)
IQVIA Holdings Inc.
IQVIA Biotech is seeking a Safety Specialist (Home/Office-Based) with experience in medical device a plus:
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.
May serve as Safety Management Lead on small to moderate sized studies that are simple to moderate in complexity and scope of work with support from senior staff.
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
- Contacting sites for missing and/or unclear information
- QC of cases and provide feedback as appropriate
- Generating regulatory reports
- Generating metrics
- May serve as Safety Management lead or back-up lead on small to moderate sized studies that are simple to moderate in complexity and scope of work with guidance from senior staff. 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
- Mentoring of staff on safety processes
- In collaboration with manager, supports 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.
- Communication with the client or internal stake holders as applicable.
- Performs other related duties as assigned or requested department Management.
KNOWLEDGE, SKILLS AND ABILITIES:
- In depth knowledge of clinical research process and medical terminology.
- Able to identify, analyze and problem solve moderately complex issues and trends with guidance and support from senior staff.
- 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 Safety Management 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.
- Good 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.
- 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 and identify issues and solutions proactively with guidance and mentorship from senior level staff and/or Safety Management.
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 2 year 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.
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.