(Senior) Safety Manager (Device) - IQVIA Biotech/MedTech (Mexico - Homebased)
IQVIA Biotech is seeking a Sr. Safety Manager:
Manages and oversees the delivery of the Safety Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.
Primary responsibilities include management and oversight of Safety studies and general business support, i.e. bid defense activities.
It also includes coordination or leading of departmental quality and training initiatives.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Collaborates with Safety Leadership (Assoc Director level & above) in designing and planning the work strategy of the Safety Management Department.
- Implements Safety Management Department work strategy through delegation, mentorship and supervision of Safety Management Department staff and studies.
- Oversees the start-up and ongoing conduct of Safety Management services for new studies, providing guidance and mentorship to Safety Management Lead and staff as needed. Communicates regular updates and promptly escalates any issues or concerns related to study conduct or staff performance to applicable Safety Leadership.
- Updates and develops department specific SOPs and Working Practices.
- Monitors and manages the daily activities of safety team members assigned to projects managed.
- Provides ongoing coaching and development for staff assigned to project teams, if applicable.
- Organizes and gives training sessions for project teams and Safety Management Department to ensure quality of all safety data.
- Proactively supports Business Development in all safety related issues required for the preparation of proposals/ contracts for potential sponsors. This involves participation in teleconferences and bid defense presentations as needed.
- Performs other related duties as assigned or requested by the Safety Leadership.
KNOWLEDGE, SKILLS AND ABILITIES:
- In depth knowledge of clinical research process and medical terminology.
- Broad based expertise in clinical trial safety.
- Excellent written and verbal communication skills. Able to effectively express complex ideas.
- Positive attitude and ability to interact effectively with all levels of staff to successfully coordinate, execute and oversee Safety department activities and staff.
- In depth knowledge of issues/considerations involved with collecting safety data in an electronic data capture environment.
- In depth knowledge of current ICH/GCP guidelines applicable to the conduct of clinical research.
- Excellent organizational and interpersonal skills.
- Ability to reason independently and effectively problem solve complex issues.
- Excellent attention to detail.
- Demonstrates excellence in customer service and professionalism.
- 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.
- Independently prioritizes time effectively based on department needs. Consistently meets deadlines.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Ability and willingness to travel domestically and internationally
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
- Minimum of 7 years of relevant experience in clinical trial safety.
- History of strong leadership skills including supervisory experience desirable, but not required.
- Equivalent combination of relevant education and experience.
- Advanced computer literacy and skills in 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 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.
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