Arriello is a leading consultancy and solutions provider of risk management and compliance services to Pharmaceutical and Biotech companies.
We have teams working in premarket approval and post market Regulatory Affairs, Pharmacovigilance & Quality Audits,
We are a friendly, open company with people across 11 countries and we support clients across more than 120 countries
Clinical Safety Manager
- Manage Clinical Safety projects, in cooperation with the Project Manager.
- Execute project tasks specific to the unit.
- Delegate activities to other team members within the unit (CS Assistant) as and if required and ensure a high quality of the services provided.
- Deliver solutions to issues in collaboration with external partners and internal stakeholders.
- Cross-functional teamwork, based on transparency, trust and clear communication, to ensure full compliance of the project activities.
- Improvement of Clinical Safety processes, ensuring a smooth run of the project, tasks, and processes; ability to capture all running projects, tasks and processes and their relations to other units within the CS department.
- Train junior colleagues working on similar projects.
- Cross-functional collaboration with key stakeholders/customers, both internal (e.g., Commercial, Technical, Quality, Regulatory, Pharmacovigilance, etc.) and external (e.g., Competent Authorities, Clients, External Vendors, etc.).
- Cross-functional collaboration with PV department (SAE/SUSAR, Regulatory Intelligence, Literature Monitoring, Signal Management etc.)
- Cross-functional collaboration the Medical Writing department in Development Safety Update Report (DSUR) preparation, when and if needed.
- Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place.
- Act as the project primary contact point for project-related matters and technical questions.
- Create/Review of Safety Management Plans.
- Perform risk management to anticipate and migrate any potential risks, in collaboration with the Project Manager.
- Act as Responsible Person or deputy for EudraVigilance, as applicable.
- Sponsor/users/product EudraVigilance registration and maintenance, in collaboration with the PV department.
- Input/revision of other Clinical Safety documentation (e.g., reconciliation plans, Investigator’s Brochure, protocol, reconciliation plan, medical monitoring plan, etc.), in collaboration with the PV department.
- Oversight of the Safety Committees set-up (including charter creation), coordination, and meetings management.
- Generate metrics and status reports (e.g. monthly summary report) for clients and monitor upcoming deliverables.
- Participation in audits and inspections and support with document preparation.
- Oversight of open CAPAs and Change Control processes related to the project, in collaboration with the Project Manager.
- Support with activities related to scoping Clinical Safety opportunities.
- Participate in bid defences with current and potential clients, as and if required.
- Continuous development in PV skills, involvement in continuous QMS process/systems improvement initiatives, etc.
- Bachelor’s degree or graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences – advanced degree (e.g., masters) preferable
- Minimum 3 years of industry experience (Pharmaceutical/Pharmacovigilance) working in a medical or safety department with demonstrable expert knowledge of medical terminology.
- Demonstrated progressive professional development in clinical safety or other clinical trial role.
- Relevant demonstrable knowledge of PV processes, directives, regulations, and guidelines (ICH, GVP, GCP, CIOMS, etc.)
- Experience with managing Clinical Safety projects
- Experience with QMS process/systems improvement initiatives, is desirable.
- Experience with audits and inspections in a clinical setting, is desirable.
- Fluent verbal and written English.
- Excellent team player, able to build an effective team.
- Organizational and time-management skills, able to prioritize work and adhere to deadlines.
- Excellent communication skills.
- Maintains a positive, result-oriented work environment
Informace o pozici
- Arriello s.r.o.
- Olivova 2096/4, Praha – Nové Město
- Required education: Bachelor's
- Required languages: English (Proficient)
- Benefits: Bonuses, Cell phone, Notebook, Flexible start/end of working hours, Meal tickets / catering allowance, Holidays 5 weeks, Refreshments on workplace, Contribution to sport / culture / leisure, Sick days, Occasional work from home, Work mostly from home, Individual schedules of working hours, Dog-friendly office, The possibility of study leave
- Listed in: Pharmaceutical
- Employment form
- Employment form: Full-time work
- Contract duration
- Contract duration: Permanent
- Employment contract
- Employment contract: employment contract
- Employer type: Employer
Arriello s.r.o., Hilda Grace
+420 604 575 367
+420 604 575 367