A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Senior Clinical Safety Scientist
Job Description
To support the operational processes involved with ensuring that Novartis UK complies with strict regulatory requirements for pharmacovigilance of both its marketed and investigational medicines. In addition staff management and business/DS&E functional area responsibility. Ensure all cases meeting strict timelines as defined in SOP/WP are processed daily, aiming for 100% compliance with regulatory requirements. Evaluate adverse event information, proactively following up cases for completeness, tracking to completion and alerting business (within areas of responsibility) to emerging safety issues and providing support as required. Ensuring all data entered into safety systems meets quality standards outlined in business procedures. Work with key business stakeholders to ensure adverse event reporting procedures are in place, process is optimal and appropriate reconciliation activities are undertaken with defined KPIs. Ensure business associates are aware of their role for reporting adverse events and ensure trained as appropriate. Participate and lead in cross functional and intra departmental project teams to maximize efficiency and quality for processes. Deputise for Clinical Safety Operations Manager as required. Responsible for daily workload management in conjunction with operational manager. To feedback any regulatory compliance and quality issue to associates in conjunction with operational manager. Act as mentor for less experienced associates. In conjunction with operational manager build ensure capability of operational team in line with business strategy.
Candidate Profile
Life science or pharmacy degree essential, Diploma in Pharmacovigilance or other post graduate qualification an advantage. English At least 3 years previous pharmacovigilance experience in either industry or health authority setting. Previous management experience desirable.
Additional Information:
Experience: Min. 3 Years
Location: London-West
Industry Type: Pharma/ Biotech/Clinical Research
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 153179BR
End Date: 20th March, 2015
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