Clinical Safety Manager, Administrativa - Česká republika, abroad

The position acts as a main point of contact for clients, performing high level technical activities, and overseeing the activities performed within the project by the team.

What will be your key responsibilities:

Cross-functional collaboration with key stakeholders/customers, both internal (e.g., Commercial, Technical, Quality, Regulatory, 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 with 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.
Support in business review meetings (Client visit).
Create/Review of Safety Management Plans.
Perform risk management to anticipate and migrate any potential risks
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 project specific safety database set-up and maintenance.
Oversight of the Safety Committees set-up (including charter creation), coordination, and meetings management.
Provide training to study teams on safety reporting (e.g. review of training materials).
Provide training to project team members, other CS department employees, other departments on technical areas, as needed.
Coordinate the trainings for Clients and external local partners (e.g., safety database, safety training, investigator meetings, etc.).
Oversight of all the other technical deliverables performed by the PV Department, as per the contractual agreements.
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.
Improve teamwork collaboration by sharing best practices.
Identify gaps and areas for improvement and lead remedial actions and initiatives.
Support with activities related to scoping Clinical Safety opportunities.
Participate in bid defences with current and potential clients, as and if required.
Participate in company and client meetings and trainings.
Organise and file documentation according to the company’s document management system.
Use the company’s databases, systems, and any other IT tools applicable for the job.
Continuous development in PV skills, involvement in continuous QMS process/systems improvement initiatives, etc.
Act as a process owner for assigned Clinical Safety processes.

What experience should you have:

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.