Clinical Safety Manager

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.

Details.

Location: abroad
Employment: full-time, contract
Education: master degree
Language: English (C1)
For graduates: no
Salary: by agreement

Benefits:

  • Friendly work environment
  • Multinational team with 30 nationalities
  • Flexible working hours, working from home
  • Remote work is possible
  • Meal vouchers, Multisport card
  • Dog Friendly office

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.

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