Safety Manager, Medical Device (Home/Office-Based) - IQVIA MedTech
Ensures the safety reporting within clinical medical device studies is performed in compliance with regulatory requirements, timelines, applicable guidelines (e.g. ICH-GCP, ISO 14155, FDA 21 CFR), IQVIA MedTech SOPs and agreements with the client and coordinates the CEC/DSMB activities.
Guides, supervises and evaluates the performance of the Safety Specialists. Manages the overall safety-related activities in a clinical project in order to minimize possible risks related to its execution
Essential Job Functions, Duties and Responsibilities
- Responsible for the set-up and execution of safety related tasks within the designated clinical projects in compliance with the regulatory requirements throughout involved countries with reference to the relevant legislations, applicable guidelines and IQVIA MedTech SOPs.
- Acts as an intermediary between the different parties involved, which may include a Data Safety Monitoring Board, Clinical Event Committee, Regulatory Authority, Ethics/Review Committee and the client.
- Supervises event narratives creation to assure accuracy and completeness.
- Drafts and finalizes study safety manuals and other related documents.
- Communicates with Reviewing Committees, Regulatory Authorities and CEC/DMC members.
- Ensures compliance with safety submission timelines.
- Acts as a primary contact person for all safety related aspects within the organization.
- Evaluates and formulates recommendations or improvements to company systems & processes to ensure clinical study safety issues are identified and resolved.
- Writes and/or provides input to department specific SOPs and Working Practices.
- Controls the safety budget per project in close cooperation with the client and the Clinical Project Manager.
- Assures adherence to ICH-GCP, compliance with IQVIA MedTech safety SOPs, study procedures and manuals.
- Attends study-related, company, departmental, and external meetings, as required.
- Provides ongoing coaching and development for staff assigned to safety projects.
- Performs other related duties as assigned or requested.
Knowledge, skills and abilities
- Higher educational degree (BSc, MSc) in a medical or science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.
- At least five years of the clinical research experience with two years in a medical device/drug safety/(pharmaco)vigilance related function.
- Equivalent combination of relevant education and experience.
- In depth knowledge of clinical research process, medical terminology, ICH-GCP, ISO 14155 and applicable FDA regulations and guidelines.
- Excellent written and verbal communication skills.
- Knowledge of electronic data capture systems.
- Excellent attention to detail, interpersonal and organizational skills.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Ability to work independently, prioritize effectively and work in a matrix team environment required.
- Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
- Advanced computer literacy and skills in working with Microsoft Office (Word, Excel, PowerPoint) 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 email@example.com to arrange for such an accommodation.
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