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Medical Pharmacovigilance Officer

Location: Connaught
Reference no. : 1618
Date added: 23/09/2019
Salary: €Neg



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

Person Specification:

-    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 jobs@bdr.ie



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