Manager, Safety Reporting (United States or Mexico), IQVIA Biotech

IQVIA Biotech is seeking a Manager, Safety Reporting in either the United States or Mexico. Candidate must have experience working in clinical safety preferably within a Clinical Research Organization:

BASIC FUNCTIONS:

Oversees and manages global safety reporting activities within Novella Global Safety Management including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MDs) according to applicable regulatory requirements.

Performs and oversees research and assessment of safety related regulatory intelligence globally.

Coordinates and oversees submissions by assigned staff.

Ensures compliance with applicable regulations and internal metrics.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Maintains/acquires in depth knowledge of global safety regulations as applicable to Novella business
• Oversees and trains safety staff on applicable safety related regulations
• Serves as safety reporting resource for project teams, management and clients as requested
• Develops and maintains applicable controlled documents (i.e.  SOPs, WPs)
• Develops and maintains templates for project specific documentation (i.e. Safety Reporting Plan) and provides support for implementation if needed
• Supports project teams in regards to safety reporting process setup and maintenance
• Reviews, approves or provides input into global safety reports, as necessary
• Cooperates with other departments and functions as required to support on-time submissions
• Contributes to development and implementation of KPIs related to safety reporting
• Contributes to development and implementation of metrics related to reporting compliance and productivity
• Supports development of budgets and proposals as required
• Supports other business development activities as assigned by supervisor or designee

KNOWLEDGE, SKILLS AND ABILITIES:

• Full ability to understand the significance of timelines and willingness to make all efforts to meet deliverables
• Ability to work independently, prioritize effectively and work in a matrix team environment
• Professional level knowledge of GCP/ICH guidelines for conducting clinical research.
• Good knowledge of Medical Device regulations, both pre- and post-marketing
• Very good knowledge of electronic safety databases (preferably including Argus)
• Good knowledge of electronic safety reporting systems (e.g. EudraVigilance, safety database gateway)
• Solid quality assurance skills, e.g. for development and maintenance  of compliance metrics, management of CA/PAs
• Ability to form strong working relationships across functional areas
• Ability to motivate, manage and grow assigned team members
• Excellent written and verbal communication skills required
• Excellent computer literacy including experience of working with Microsoft Office PowerPoint, Visio desired

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties
• Ability and willingness to travel domestically and internationally, if required.

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's Degree in a relevant medical / scientific area (i.e. nursing, pharmacy, pre-medicine, clinical research etc.) or equivalent (e.g. experienced healthcare professional.)
• At least 7 years of overall Safety / Pharmacovigilance experience with an emphasis on regulatory safety reporting
• Appropriate clinical research experience including electronic data management systems, EDC, safety database usage
• Professional knowledge of issues affecting Safety / Pharmacovigilance reporting for clinical trials of IMPs and medical devices
• Documented continuing education in Safety / Pharmacovigilance with an emphasis on global safety reporting for drugs and medical devices.
• Prior experience with EudraVigilance submissions required
• Prior experience with use of regulatory databases (i.e. Cortellis) preferred
• Prior experience with staff line management (hiring, training) required

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_recruiting@iqvia.com to arrange for such an accommodation.