Clinical Safety Manager

ROLE DESCRIPTION:

• 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.

KEY RESPONSIBILITIES:

• 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.

MINIMUM QUALIFICATIONS:

• 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