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Global Safety Medical Director

  1. London
Uxbridge
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
31947

This vacancy has now expired

Global Safety Medical Director – Pharmaceuticals – Uxbridge

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Global Safety Medical Director. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on in the UK.

Responsibilities:
  • Analyse safety data from clinical studies and review clinical study reports as needed
  • Evaluate safety signal detection findings validate signals and determine a need and develop a strategy for further analysis
  • Decide on need for further actions on safety issues and in conjunction with the TAH and assigned PVSs lead a cross-functional discussion
  • Documents work as required in the safety information management system
  • Prepares and presents recommendations on safety issues to the Global Safety Team and escalates, and in conjunction with the TAH and PVS present the data to the executive level cross-functional decision-making body
  • May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • Risk management and minimisation activities
  • Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document
  • Develop materials for additional risk minimisation measures as applicable to role
  • Periodic (aggregate) safety reporting
  • Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER, DSUR)
  • Develop a strategy for and lead preparation of response to regulatory agency inquiries on safety topics related to regulatory filings
  • Review and assist in development of Paediatric Investigation Plan (PIP)
  • Prepare for and attend health authority meetings involving patient safety issues
Required experience:
  • Processes and regulations for pharmacovigilance and risk management
  • Advanced understanding of interfaces across various pharmacovigilance and risk management processes
  • Drug development and lifecycle management
  • Safety data capture in clinical development and post-market settings
  • Safety database structure and conventions
  • MedDRA and other dictionaries used in pharmacovigilance
  • Methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology, and pharmacology
  • Internal organisational and governance structure
    • Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
    • Signal detection and evaluation
    • Document writing and source document review
    • Basic skills in application of statistical and epidemiological methods to pharmacovigilance
    • Advanced skills in application of statistical and epidemiological methods to pharmacovigilance
If this role is of interest, please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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