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Our very respectable client is looking for a Regional Associate Director to join their team on a permanent basis. This role is an excellent opportunity work in compliance, auditing, training and risk. This is a great role if you are looking for variety and career progression.
There is also the possibility of a couple of days home working.
Job Description : The Regional Associate Director is responsible for a number of specific countries as determined by the Senior Director, Affiliate Vigilance Excellence. The purpose of the role is to have oversight of the performance of Affiliate pharmacovigilance functions in a given region to ensure they are in line with company standards and local legislative requirements.
Local compliance monitoring is the responsibility of the Affiliate. The Regional Associate Director must be aware of performance of Affiliates in their countries of responsibility and work with ASRs to ensure:
o Timely investigation and review of any non-compliance issues o Appropriate CAPA activities and completion of activities o Compliance trending within and across regions o Escalation of issues to QSCTO, GPV and QPPV o Compliance with worldwide regulations
2. Audits and Inspections
o Provide input to risk-based audit schedule o Provide support to regional Affiliates for audit and inspection preparation using a risk based approach o Assist Affiliate with development of audit corrective action plan or provide input to inspection response as appropriate
o Responsible for ensuring new ASRs are appropriately trained utilising most appropriate medium and format for a given region.
Support implementation of global SOPs at local level. Where global SOP requires action at local level must monitor/track timely completion.
o Activities should take into account local legislative requirements.
5. Advice and guidance
Provide ad hoc advice and support to ASRs on operational PV issues and liaise with GPV for resolution.
6. Local SDEAs
o Provide support and advice to Affiliate on development of local SDEAs and reviews before submission to GPV for final review.
7. Regulations and guidelines
o Understand local regulations and guidelines and assess potential impact on global process and procedures.
8. ASR Development
o Provide feedback on potential ASR talent which may be redeployed in other regional/global PV roles o Work in collaboration with IMD to assist in ASR development e.g. involvement in GPV initiatives/projects
9. Process Improvement
Provide local area perspective on processes to GPV to enhance productivity and efficiency
o Application and maintenance of consistent standards for PV across all Affiliates o Adherence to global and local SOPs o Appropriate and adequate training for ASRs o Timely identification and appropriate response to areas of non-compliance o Audit and inspection readiness in Affiliates at all times o Real-time response to ASR questions