Associate Safety Manager, IQVIA Biotech (United States or Mexico)
IQVIA Holdings Inc.
IQVIA Biotech is seeking an Associate Safety Manager in United States or Mexico. Must have experience working in clinical research:
Performs Sr. Safety Specialist functions with the addition of:
- Independently serves as Safety Management Lead on multiple complex studies/programs with minimal to no oversight and guidance
- Consistent demonstrated ability to think outside of the box
- May perform Safety Manager tasks as assigned
This position is held by staff with extensive clinical research experience and consistent demonstration of leadership skills including initiative.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Performs safety case processing tasks including, but not limited to:
- Intake tasks as applicable for assigned projects
- Review and Triage of incoming safety information
- Writing clinical narratives
- Generating queries including drafting of medical queries
- Follow up with sites for missing and/or unclear information
- QC of cases and provide feedback as appropriate
- Generating regulatory reports
- Generating metrics
- Serve as Safety Management lead on large sized and global studies/programs that are 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
- Presentations for team and client representative
- Training of internal and client 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 Safety Management Manager
- Assists with bid defenses or other business development activities
- Mentors and trains new Safety Management staff
- Assess and analyze team’s performance and ensure appropriate initiative is taken as required
- Performs other related duties as assigned or requested by Safety Management
KNOWLEDGE, SKILLS AND ABILITIES:
- Demonstrates expert knowledge 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 internal and external 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 plus 5 years relevant safety experience including at least 2 years in a senior level position.
- Equivalent combination of relevant education and experience.
- Advanced Computer literacy and skills working with Microsoft Office (Word, Excel, PowerPoint) required.
- Knowledge of electronic data capture systems and safety database systems 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.
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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 workday[email protected] to arrange for such an accommodation.