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Global PV Operations Manager

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Pharmacovigilance Jobs
Country:
United Kingdom
Region:
Hertfordshire
Contract Type:
Permanent
Currency:
£
Salary:
55,000 to 65,000 per annum
Posted:
12-Jul-18
Recruiter:
Key People
Job Ref:
BBBH23456

An excellent opportunity has arisen for an experienced PV Manager to join a relentless and passionate team based in Hertfordshire. Within this role you will manage the UK PV Operations team.

Responsibilities:

*Continue to work effectively, efficiently and build even stronger relationships with teams within Global Product Safety, Clinical, Regulatory Affairs and associated business partners/CROs. Thus, ensuring patient safety is kept at the forefront without compromising commercial opportunities to advance the company as the leading worldwide provider of generic medicines.
*Ensure quality, accuracy and consistency of global ICSR through retrospective QA process & publish them observations on periodic interval
*Preparation and review Global procedural documents covering PV OPs (Pharmacovigilance Operations) processes and procedures for all territories and harmonise them.
*Conduct impact assessment for global Pharmacovigilance legislation with specific focus on EU legislation on PV Operations related functions and ensure compliance for all territories.
*Act as PV OPs subject matter expert (SME) on the ARGUS database upgrade project & contribute to the validation and implementation of the new Global Safety Database. Responsible for setting up training material to ensure consistency of data entry of ICSRs for all data entry sites.
*Manage the UK PV Operations team; Encourage, support and motivate members of the PV Operations team to take responsibility and share and display the core values of the company.
*Assist PSRM Compliance with both internal audits of Affiliates. To act as SME - in Regulatory Inspections & audits (preparation, participation in interviews and CAPA management) for all territories.

Qualifications:

*Life sciences degree
*In depth ICSR experience
*Line management experience
*The ability to solve problems and provide solutions
*Excellent computer skills by using MS Word, Excel, and Outlook

For further details about this role, or other positions within PV, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk


Closing Date:
20/07/2018

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