Purpose & Scope:
Performing operational activities, implementing and maintaining operational plans and tools to support the QPPV Office for the maintenance of the pharmacovigilance System Master File (PSMF).
Collaborating with the QPPV Office team for the development of procedures and projects to ensure compliance with all applicable global requirements for the PSMF and EU-QPPV oversight.
Collaborating with relevant GPV and non-GPV partners (e.g., Global Clinical and Research Quality Assurance, Glob al Regulatory Affairs) for the maintenance of the Pharmacovigilance System Master File (PSMF).
Reports to the the Associate Director QPPV-Office . Is a member of the QPPV Office team and contributes to the development, implementation and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
Essential Job Responsibilities:
Global implementation and maintenance of PSMF and QPPV oversight
Responsible to complete and maintain the administrative tools used for the PSMF maintenance process; for example, but not limited to Tracker and QC Check list and Tracker, Name list . Monitors compliance with timelines for the responses from PSMF stakeholders and quality of responses to ensure compliance with the PSMF maintenance process
Ensures that the document Management System used for the storage and archive of the PSMF contains the most up-to-date version for each section or annex, as provided by the PSMF stakeholders to ensure publication and submission of the PSMF within agreed timelines. .
Supports the QPPV Office team members, when providing feedback and appropriate support to PSMF contributors within and outside GPV if required.
Contributes to the Quality Check of the PSMF sections and annexes using the PSMF QC checklist and provides appropriate feedback to the PSMF stakeholders when applicable.
Support the QPPV Office team for audit/inspection readiness activities, implementation of corrective actions & preventive actions with regards to the PSMF and QPPV oversight
Process Improvement PSMF maintenance
Collaborates with the QPPV Office Team concerning process improvement of the PSMF maintenance activities by developing tools and processes.
Supports QPPV Office staff on projects to improve regulatory compliance and GPV processes, provide support by planning and coordinating meetings, taking minutes and independently performing activities as directed by the project lead
Supports the Global PV training to ensure PSMF maintenance and QPPV oversight by all staff by ensuring that all stakeholders are notified and reminded for applicable training(s). If applicable, facilitate training sessions with appropriate stakeholders.
Provide administrative support, including the development and maintenance of training overview for all relevant contributing teams (40+) and stakeholders (200+) within the company globally
Support the maintenance of the QPPV Office Share Point Sites
Responsible archiving documents and emails related to PSMF maintenance
Monitoring QPPV email inbox and flagging PSMF related content to the appropriate QPPV Office staff
Taking minutes in QPPV Office functional meetings
Support Global PV staff of approximately 200 individuals by offering consultation, advice, and subject matter expertise.
Supports audit/inspection readiness of Global PV processes and staff in regards to the PSMF and QPPV oversight.
These activities have major significance to the GPV organization, and require in-depth subject matter expertise, strategic thinking and leadership skills to effectively manage complex operations resulting in regulatory controlled deliverables with external partners.
Reports to the QPPV-Office Team lead or EU-QPPV and works under supervision and in support of QPPV Office (Sr) Manager(s). Peers include QMS Associates and Associates Managers and other GPV team member
What we offer
What we offer
What we offer:
A full-time position until March 2022;
A salary between 2700 and 3000 euros (based on knowledge and experience);
A nice challenge in an international company.
You speak English and Dutch very well;
You live in the area of Leiden;
Minimum of 2 years in pharmaceutical, biotechnology, or related industry;
Minimum 1 year significant experience in Pharmacovigilance, Regulatory affairs or Safety Quality Assurance, including establishing standards in support of the safety quality systems, especially as they impact and influence multiple departments and levels of management;
Understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations, experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle;
Understanding of PV and Clinical Research processes, and other processes making up the PV system, including the interfaces between these processes;
Good understanding of PV, data management and adverse event reporting and processing;
Excellent oral and written communication skills, ability to interact with all levels of personnel;
Must be able to communicate in English (active and passive), other languages considered an asset;
Computer literacy (including Microsoft Office, Access and Project).
About the company
About the company
The company you will be working for is located in Leiden. They have several properties located all over the world. The organization has a great knowledge and experience in the medical industry. They develop drugs, medications all over the world.
You will be working in the office in a team. The company is from Leiden Central Station 16 minutes walking or 4 minutes cycling.