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Compliance and Safety Review Pharmacovigilance Manager

Are you an experienced PV professional? Do you have strong compliance experience? Great leadership skills? ..

My client a top Pharmaceutical company has a vacancy for a Pharmacovigilance Compliance and Safety Review Manager to join the compliance and Safety review team.

Within this role you will:
Lead the UK PhV Compliance team activities and act as line manager for the PhV Compliance and Safety Review team

Act as the expert for Pharmacovigilance Team compliance issues, CCSI and Risk Management Plans.

Act as back-up Pharmacovigilance Compliance/Safety Review Officer when required and have an oversight of all tasks carried out by the team.

Continuously monitor and strengthen processes to ensure timely reconciliations, audits, training activities, SDEAs, CAPAs, CCSI and RMM.

Maintenance, update and review of local controlled documents relating to Safety Review team responsibilities to ensure compliance with global/EU standards and to manage and co-ordinate process optimisation for the UK PhV Safety Review team as necessary

To perform Company Core Safety Information and SmPC/PIL review, and support the review and implementation of UK National labelling changes.

Ensure Compliance and Safety Review team members are fully supported, mentored, trained and encourage ongoing development Develop and/or utilise compliance monitoring outputs to appraise team on productivity/quality/compliance regularly Feedback team performance vs. KPIs to Director, UK PhV & LSO as applicable and via input to regular departmental meetings and reports demonstrating KPIs and key successes of team

Ensure Compliance and Safety Review team objectives are assigned annually and reviewed during regular 1:2:1s to ensure delivery on time and according to the PhV Leadership Strategy

As a member of the PhV Leadership Team provide ad hoc support to other team tasks upon request of Director, UK PhV & LSO Act as Deputy LSO ensuring LSO responsibilities undertaken in the absence of the LSO

To be considered for this role you will possess a Life Science degree with significant experience within Pharmacovigilance within the industry. Expert experience within compliance, safety agreements and safety reviews is a must.

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on 0203 465 0045.


Summary

Job Type:
Permanent
Industry
Pharmaceuticals
Location
Hertfordshire
Specialism
Life Sciences
Pay
£50000 - £60000
Ref:
3022537
Apply Now

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