The purpose of this role is to provide operational support to the Office of QPPV to maintain the Jazz and PBL Pharmacovigilance System Master Files (PSMFs) and to facilitate QPPV oversight.
Serve as the PSMF Administrator for the Jazz and PBL PSMFs;
- Coordinate the ongoing regular maintenance of the PSMFs and PSMF Summaries in accordance with the assigned schedule, and under the supervision of the Deputy QPPV.
- Maintain schedule of updates and data requirements for the PSMFs
- Ensure the content of the PSMFs is compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions
- Ensure the content of the PSMFs is provided in a timely manner, collating the data, resolving queries and ensuring review, approval and release of the document as appropriate
- Upload completed PSMFs and PSMF Summaries into document repository and ensure relevant documentation is archived in accordance with company requirements
- Ensure that the QPPV/Deputy are made aware of significant changes and updates of the PSMF content and/or format on a regular basis
- Support the preparation and maintenance of PSMF-related documentation in other regions outside of the EU/EEA (e.g. National Pharmacovigilance Sub-System Files (PSSFs) for Arab League countries)
- Ensure appropriate and current procedural documents are in place for the maintenance of the PSMFs
- Perform other PSMF-related activities, as appropriate
Provide support to the QPPV/Deputy for the oversight of activities and interactions with internal departments and external business partners (e.g. affiliates, distributors , marketing partners, third party service providers) , including but not limited to:
- participate to meetings, when required
- set up meetings, prepare agendas and minutes, when required
Provide support to the QPPV/Deputy for internal PV audits and regulatory GPvP inspections, including:
- assisting with the readiness, preparation, facilitation and follow-up of PV audits and regulatory GPvP inspections
- assisting with the development, management & implementation of corrective & preventative actions (CAPAs) arising from PV audits and inspections
Provide support for ongoing awareness of proposed and required changes to PV requirements, including:
- Perform gap analysis and/or impact assessments on the PSMFs and/or related documents
- Implement new/revised processes to maintain continued compliance with PV requirements
- Prepare new/update existing procedural documents
Provide support for other Office of QPPV related activities under the direction of the QPPV/Deputy, as appropriate
Required Knowledge, Skills, and Abilities
- Good knowledge of EU/EEA and international pharmacovigilance
- Previous experience in PV and/or Quality; previous experience with PSMF support is preferred but not essential
- Technical understanding of audit preparation and dealing with CAPAs
- Strong planning, tracking and coordination skills
- Experience with Microsoft Word, Excel and PowerPoint; ability to learn to use other applications, as required
- Excellent interpersonal and communication skills, both written and verbal, and fostering effective collaborations across departments
- Fluent in English, both written and spoken
- Able to identify and implement process improvements
- Able to work on multiple tasks simultaneous with limited supervision
Required/Preferred Education and Licenses
- Life Science, pharmacy or nursing degree
- Experience in Pharmacovigilance/Drug Safety or Quality required; experience working closely with or within a QPPV function preferred but not essential
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an Equal Opportunity Employer.