- Support the Quality system (eQMS), which includes supporting the management and Quality Assurance review and/or approval of Change Controls, Deviations, associated CAPA, extension requests
- Support PV process improvements including review and/or approval of controlled documents, as required, as it relates to Quality Assurance activities, meeting with subject matter experts to revise procedures and merge procedures, as part of continuous improvements
- Support the oversight conducted by the Qualified Person for Pharmacovigilance (QPPV) by providing records' data/information from the eQMS as requested by the Office of the QPPV and as per governing procedural document(s) owned by the Office of QPPV.
- Support timely completion of eQMS records and the progression status of records within the eQMS by conducting follow-up activities and communications with aging/overdue record owners and inform Sr. Leadership on a routine basis.
- Assist in inspection related activities, pre, during, and post inspection, such as backroom support and document request
- Assist in developing and monitoring of CAPA from audits and regulatory inspection
- Help to ensure the development, effectiveness evaluations, and compliance with PV SOPs, as needed. Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure PV SOP alignment
- Monitor global pharmacovigilance regulatory intelligence to determine impact on pharmacovigilance quality system, as needed.
- Make contributions to the PV System Master File (PSMF) as a Primary Key Stakeholder (KSH) to ensure it is maintained on a regular basis
- Contribute to the collection, organization, and presentation of all required global PV compliance metrics including vendor and partner oversight metrics, as needed.
- Support the development, design & maintenance of PV compliance metrics, as needed.
- Assist CPVQA/ Quality team in preparation and inspection activities during Regulatory Agency inspections and internal audits
- Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting PV, and develop strategies to support the patient safety at the local level
- Support end users of the eQMS by performing the role of superuser of the Reliance eQMS since implementation of the Reliance system in 2012 to present day.
- Minimum 5 years' experience in Pharmaceutical industry
- Knowledge of Pharmacovigilance requirements of PV including FDA, EU GvP, and ICH guidelines
- Excellent verbal and written communication skills
- Must have strong interpersonal/organizational skills
- Ability to work alone, and as part of a team, delivering on CPVQA Team objectives
- Strong negotiation skills
- Ability to influence without authority
- Excellent collaboration skills
- Evaluative, analytical, and interpretative skills enabling review and development of data/trending
- Must be comfortable in a fast‐paced, demanding work environment
- / or equivalent experience in a drug safety or clinical environment with a minimum of five (5) years of direct DS&PV and/or GCP experience; or
- MS/MA degree in related discipline and three (3) years of related experience
- Equivalent combination of education and experience
Manager, Quality and Compliance - Dublin, Ireland - Jazz Pharmaceuticals
Description
Brief Description:
The Manager of Quality & Compliance (Q&C) for Pharmacovigilance (PV) is responsible for performing quality assurance activities to ensure that Jazz is adhering to Global applicable regulations, industry standards, Jazz policies, procedures and quality standards in support of the Quality Management System within the Research and Development (R&D) Organization.
In addition, the Manager will support Jazz leaders in identifying and communication of compliance risks, oversee action plans to mitigate risks (if applicable), and be actively involved in inspections and inspection-readiness activities. This person will participate in interdepartmental teams representing Clinical and PV Quality Assurance (CPVQA) and at times may be asked to perform CPVQA activities to support other GxP areas, quality operations, and global quality systems.
Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the development and management of continuous improvements, including the implementation, tracking, maintenance, and effectiveness checking of all PV related activities.
Essential Functions/Responsibilities
Required Knowledge, Skills, and Abilities
Required/Preferred Education and Licenses
FOR US-BASED CANDIDATES ONLY