Company: Mosaic Regulatory Solutions
Closing Date: 17 Nov 16
Salary (£): On Application
To apply for this Global Safety Manager role please call Julie Cooper on 07951 082482 or send your CV in confidence to :email@example.com
Role :Manager, Global case management & reporting- PV / Drug safety
This company is one of the largest companies in the consumer health and personal care industry in Europe. It has managed to build a high performance, customer-focused organization which today is directly active in 35 countries, serving a high potential market of prescription-free, consumer-oriented health products. Its headquarters are based in Nazareth, Belgium.
Rapidly expanding company constantly looking for dynamic people who are ready to take a new challenge.
To strengthen the Global Safety Surveillance Team they are currently looking for a Manager, Global case management & reporting (m/f).
You will be directly reporting to the Director, Head of Global Safety Surveillance.
Management, Strategy &Continuous Improvement.
Previous experience in setting up effective case processing workflow with internal delays
Leads Drug Safety Officers involved in the collection, processing, evaluation and reporting of adverse events on marketed products.
Leads Case Handling meetings to ensure quality and consistency across Case Handling Groups.
Responsible for resource planning, performance management and objective-setting in line with departmental objectives, training, development and coaching of direct reports, work prioritization, delegation and issue resolution/escalation for team.
Develops Case processing Strategy and implementation of periodic KPI plans/metrics
Proactively identifies business drivers and changes that may affect current processes; ensures implementation of required changes into current processes.
Continually reviews/challenges department processes to identify opportunities for improvement and efficiency gains.
Ensures compliance with all internal and external drug safety reporting requirements for marketed products.
Maintains up-to-date knowledge of EU and non-EU pharmacovigilance laws, regulations and guidances.
Serves as liaison between other global safety departments.
Key role in clarifying case processing workflows to different affiliates worldwide in order to implement it locally
Represents the department in global case handling discussions (coding & case handling meetings).
Serves as Subject Matter Expert and represents in audits and regulatory inspections pertaining to product portfolio.
Ensures case handling processes and case quality are in line with company and regulatory expectations regarding adverse event case handling for marketed products.
Defines and drives implementation of Corrective and Preventive Actions (CAPAs) in response to quality and compliance issues.
Responsible for handling ad hoc projects and/or safety concerns as assigned.
A life science degree (PharmD, MD, scientist …) required ; advanced degree preferred;
A minimum of7years of experience in PV/Drug safety in pharmaceutical industry Solid experience in case management/processing
Demonstrated knowledge and understanding of global drug safety and pharmacovigilance principles and processes;
Previous line management of small teams would be advantageous, however candidates with mentoring experience will be considered & who wish to develop their line management skills.
MedDRA experience required;
Experience with drug safety systems required;
Strong oral and written communication skills required;
Excellent organizational skills required and priority definition spirit
Ability to handle multiple priorities and demands in a fast-paced environment required;
Be able to work in a matrix environment whilst remaining organized at all times;
Fluent in English, other languages are an asset;
Proficient in MS Office applications (Excel, Word, Outlook).
Previous experience in safety database ARGUS/ARIS
Key words / key word: drug safety , PV , pharmacovigilance , global safety , manager , pv manager , pharmacovigilance manager , global case management , drug safety systems , case processing , case handling , EU , International
Mosaic Regulatory Solutions Ltd
|Tel:||0208 305 9733|
|Website:||Visit Our Web Site|
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