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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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.

Engineering Director
Global Pharmaceutical firm

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