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