Medical Pharmacovigilance Officer
-       Contribute to the safety monitoring of medical pharmacovigilance activities, to ensure PV obligations and requirements are met
-       Review, evaluate & collate pharmacovigilance data, reports and agreements
-       Contribute to the development of the medical Pharmacovigilance (PV) system
Duties and Responsibilities:
-       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 Safety Data Exchange Agreements (SDEAs), documents and reports necessary to maintain a compliant pharmacovigilance system
-       Contribute to the implementation of process / system improvements and updates to PV system
-      Liaising with and provide PV guidance & advice on 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 PV process are achieved
-      Prepare, maintaining and present PV Key Performance Indicators (KPI&rsquos)
-      Review of Pharmacovigilance System Master File (PSMF) and associated annexes-
-      Review and approval of signal detection reports
-      Participate in the preparation and roll out of regulatory 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
-      Manage timelines for responses to PV queries from all stakeholders and customers
-      Supporting all PV outsourced activities such as EVMPD, Medical Information, etc.
-      Manage & oversee PV variation changes and updates, transfer of PV information to other internal departments, PV SOPs 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
For further information, please contact our office on 093 41932 or e-mail your cv directly to us at firstname.lastname@example.org