Drug Safety Specialist - Based in Czech Republic or Slovakia

Role Description

Executes tasks associated with assigned projects, including without limitation:

• Act as Project Manager on assigned project(s).
• Oversee the work performed by the project team members and ensure a high standard of quality and timeliness of work delivered to the client.
• Maintain project tracking and systems; oversee project resource through time monitoring against agreed project(s); and provide agreed reports to Drug Safety department leadership and to clients.
• Support the commercial unit in scoping, proposal, and/or contractual agreements preparation;
• Assessment of technical activities required for project setup.
• Participate in business meetings, bid defences with current and potential clients.
• Leading or participating in the kick-off meetings with clients;
• Local PV network management.
• Local project management (Local literature monitoring, Local ICSR processing, LPPV/LSO management, Monthly reporting and compliance monitoring);
• Processing of safety reports (AEs/SAEs/SUSARs) including those from clinical trials and post-marketing sources– receipt, triage, safety database entry, quality control, MedDRA and WHO drug coding, expectedness and seriousness assessment, classification, tracking, coordination of medical review and assessment, follow-ups, as required;
• Support expedited submission of ICSRs to concerned parties.
• Support the reconciliation of safety reports.
• Support periodic screening and evaluation of local country reporting requirements.
• Global Literature monitoring;
• Medicinal Product Management (XEVMPD);
• Product documentation (SmPC, IB);
• Management of project related PV contracts (PV service agreements, Safety data exchange agreements);
• Management of third party deliverables and timelines.
• Support the development and revision of project specific documentation such as Project Management Plans, Safety Management Plans and Responsibility Matrices.
• Support the revision of safety documentation (e.g. reconciliation plans, SAE forms, pregnancy forms)
• Conduct project specific impact assessment for Regulatory Intelligence in different territories:
• Support Local Signal Management and Benefit Risk Management activities;
• Support provision of pharmacovigilance training to project and internal teams as well as other departments
• Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the PV department
• Is familiar with Communication pathways in projects.
• Administrative work at the department – may include, but is not limited to:
• Editing, scanning, printing and filing/archiving of the documents according to good documentation practice and Arriello quality system;
• Revision, formatting, editing of functional project documents – templates, tables, reports, manuals and plans;
• Project specification agreements/PV manuals or another PV documents preparation according to the template as needed
• Supporting reports and questionnaires compilation;
• Support with trainings (training records, filing, etc.)
• PV department tracking;
• Monitoring of Company/project specific Safety mailboxes and tracking
• Administrative support in communication with internal and external vendors
• Support of all staff in the Pharmacovigilance department in running projects or processes
• Adherence to company’s processes and systems
• Support in projects compliance monitoring (collecting data, preparation of reports)
• Organize and maintain project files and keep databases updated.

Key Responsibilities:

• Work on projects and tasks assigned by their management.
• Excellence in project support and in meeting the deadlines.
• Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place.
• Follow and achieve agreed project KPIs and KPIs of the department.
• Act as a Process owner for assigned PV processes.
• Provide training to project team members and other PV department employees on technical areas as needed.
• Participate in trainings, both internal and external as required.
• Improve teamwork collaboration by sharing best practices.
• Constantly seek for and take into consideration the client and internal feedback to improve the efficiency and quality of work within the assigned projects.
• Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables.
• Build and manage relationships with third parties and manage timely achievement of project specific deliverables.
• Ensure that all CAPAs related to assigned projects and tasks are managed within the timelines.
• Work cross-functionally and in collaboration with key stakeholders/customers, both internal (e.g., Commercial, Quality, Regulatory etc.,) and external (e.g., Competent Authorities, Clients, External Vendors, etc.,).
• Participate in business meetings with current and potential clients, as required
• Participate in audits and inspections, as required.
• Participate in company marketing and promotional activities, as and if required
• Organize and file documents according to the company’s document management system.
• Use company’s databases, systems and any other IT tools applicable for the job in line with company procedures.
• Adhere to company’s processes and systems.

• Bachelor’s degree or graduate in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences) – advanced degree (e.g., masters) preferable.
• Minimum of 3 years of experience working in a medical or safety department with robust knowledge of medical terminology or sufficient experience as assessed by the Head of Function.
• Fluent verbal and written English and Czech.
• Previous knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,) beneficial.
• Sound knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,)
• Project Management experience beneficial.
• Significant experience working with a safety database.
• 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

• Hybrid or remote working (Use of our offices in various locations, co-sharing work space or remote options available)
• 5 weeks holiday plus national holidays in your given location
• 3 personal days
• Flexible benefits, based on location
• Home office stipend
• Annual bonus program
• Other employee Bonuses (spot bonuses and employee nominated bonuses)
• Dog friendly offices