QA Pharmacovigilance Officer
- Ensure continued compliance to current EMA GVP Guidelines
- Review, evaluate & collate Risk Assessments and PhV Questionnaires
- Contribute to the development and maintenance of the Quality Pharmacovigilance (PV) system
Essential Duties and Responsibilities:
The functions of the Senior QA Pharmacovigilance Officer include but are not limited to:-
- Work closely with the Qualified Person Responsible For Pharmacovigilance (QPPV) and other members of the pharmacovigilance team / service providers, to ensure timely, effective and appropriate processing and evaluation of Audit Reports
- Review documents and reports necessary to maintain a compliant QA pharmacovigilance system
- Contribute to the implementation of process / system improvements and updates to QA PV system
- Liaising with and provide PV guidance & advice on QA PV topics to all key stakeholders
- Identify, develop and roll-out opportunities for continuous improvement in the PV system
- Work with stakeholders to ensure goals of the QA PV process are achieved
- Prepare, maintaining and present PV Key Performance Indicators (KPI’s)
- Review of Pharmacovigilance System Master File (PSMF) and associated annexes
- Participate in the preparation and roll out of Quality PV policies, guidelines and procedures
- Attend PV audits / inspections and meetings, as necessary
- Monitor company/ co-partner compliance and liaising with management to mitigate identified risks
- Establish key performance indicators (KPIs) to monitor the effectiveness and implementation of its PV systems and processes, including areas of delegation to third-party service providers and business partners.
- Manage timelines for responses to PV queries from all stakeholders and customers
- Supporting all PV outsourced activities
- Manage & oversee PV variation changes and updates, transfer of PV information to other internal departments, PV SOP’s and PV training
- Participate with inter-departments PV discussions as required
- Other ad-hoc duties as requested by Management
· 3rd level degree in a relevant scientific or PV related discipline.
- Minimum 3 years in a PV environment
- Ability to work on multiple projects simultaneously, while maintaining excellent oral, written and presentation / communication skills.
- Experience in busy problem solving environment with the ability to work to tight deadlines Excellent PV knowledge for generic products, processes and worldwide PV guidelines.
- Highly motivated person, with the ability to manage deadlines, work effectively as part of a multi-disciplinary team and ability to work unsupervised and on own initiative
· Good IT skills and computer