Global Patient Safety Manager

MSI Group Limited
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Our prestigious client are looking for a Global Patient Safety Manager who will ensure the efficient operation of processes relating to receipt and processing of safety information from all sources, the quality and integrity of all safety data, and the distribution of ICSRs and regulatory reports, in full compliance with all applicable PV legislation.

Main Responsibilities:

- This requires a good working knowledge of pre- and post-marketing pharmacovigilance legislation.
- Ensure that all current global PV requirements for case processing, literature searches and periodic safety reports are effectively incorporated into our clients processes and documented in SOPs
- Define relevant Key Performance Indicators (KPIs) and quality standards and ensure that these are measured and monitored, and implement corrective and preventive actions (CAPAs) as required
- Ensure that any changes in legislation relating to PV requirements for these activities are proactively incorporated into our clients processes so that there is no loss of compliance and business continuity is maintained
- Maintain the case-processing 'Data Entry Guidelines' including working with the GPS TA Leaders to ensure that any necessary product-specific data entry or medical evaluation instructions are included
- Ensure that all product details eg changes to the CCDS, changes in marketing authorisation status etc., are communicated appropriately to the teams who need to know to maintain compliance with these processes

Experience & Qualifications:

- Biosciences graduate or experienced healthcare professional
- Fluent in written and spoken English
- Experience with safety data management in industry or a CRO
- Good working knowledge of pre- and post-marketing pharmacovigilance legislation
- Experience of cross-functional team work
- Experience of negotiating effectively to deliver shared goals
- Prior experience with regulatory authority inspections and internal audits, either in industry, a CRO, or a health authority
- Experience in translating legislation to internal processes

Pharmacovigilance, PV, Patient, Patient safety, Information manager, Pharmaceuticals, quality standards, safety data, CAPA'S