Medical Pharmacovigilance Officer

Galway

Basic Summary:

  • 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

 

 

Essential Duties and Responsibilities:

The functions of the Senior Medical 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 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’s)
  • 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 SOP’s 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 initative

·         Good IT skills and computer

Medical Pharmacovigilance Officer

Galway