Company: Advanced Clinical Recruitment Ltd
Closing Date: 30 Dec 16
Type: Full Time
Salary (£): Competitive
Basic qualifications: • Medical degree. • Experience of working within drug safety function. • Experience in Signal Detection. • Experience of working within a Pharmaceutical, Biotechnology or Clinical Research services company. Preferred qualifications: • Rare diseases knowledge and experience is preferred.
My clients have a significant global presence with commercial operations in more than 150 countries, a network of 89 manufacturing sites, and large R&D centres in the UK, USA, Belgium and China. Their Pharmaceuticals business develops and makes medicines to treat a broad range of acute and chronic diseases. We have leading positions in respiratory disease and HIV with a portfolio of innovative and established medicines.
The role; Drug Safety Physician:
Working in partnership with the product scientist you will support the safety review of assigned products by conducting safety evaluation and risk management planning activities.
Your activities may include:
• Lead or support the proactive monitoring and evaluation of all aspects of the safety profile of designated products and ensure that optimal decisions are made at all stages of the product lifecycle.
• Lead or support the discussion and management of safety issues through matrix teams across the global organisation and present your findings to high level clinical teams and/or company governance bodies.
• Ensuring that safety documents (e.g. periodic reports, signal evaluations, labelling documents, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.
• Providing medical review and sign-off for regulatory documents including PBRERs, RMPs, and DSURs.
• Developing safety plans and strategy for safety data collection, data analysis and interpretation.
• Leading discussions relating to the management of safety issues through matrix teams, across the global organisation.
• Presenting findings to high level clinical teams or governance bodies
If you are interested in having a further discussion in regards to this role, please give me a call on 01142945005, or alternativly, email me at firstname.lastname@example.org
Regus 2nd Floor
|Tel:||0114 270 1741|
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