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Director Pharmacovigilance Compliance

Boston, MA

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nnJob DescriptionnDirector Pharmacovigilance Compliance rnDirector Pharmacovigilance Compliance rnGreater Boston arearnA pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines are currently seeking a Director Pharmacovigilance Compliance as their company is rapidly expanding! This 10 ten global pharma company has received recognition for their overall success and is looking to increase headcount within the Pharmacovigilance department. Now is a pivotal time to get in with this group as the Director Pharmacovigilance Compliance will have the ability to lead and impact their robust pipeline of promising new medicines. rnThe Director Pharmacovigilance Compliance will have the following responsibilities:rnEnsuring the compliance activities related to PV inspection/audit readiness for Global PV, coordinating with the US, EU and Japan Compliance leads and partnering with QA to determine internal PV audit areas of focus.Ensuring the oversight of the coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits in coordination with the Head, PV EU PV and Affiliate Compliance, EU QPPV and Head, Compliance, Japan PV as applicableDevelop and propose recommendations based on findings from external and internal inspections and audits worldwide to focus GPSE global Compliance more towards preventive actions to sustain our culture of zero tolerance for late cases(except for Japan and EU/EEA territories).Collaborating with QA to ensure timely audit and inspection responses for the PV function and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide (except for Japan and EU territories).Collaborating with the Global PV functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities' regulations worldwideEnsuring that adequate processes are in place to maintain current knowledge of and adherence to Compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance.Participating in talent management strategies such as annual reviews, performance management, succession planning and employee development and retention. rnThe ideal candidate will have the following skill set:rnBachelors Required. Advance degree preferred.Minimum 10 years pharmaceutical or health care related industry experience required.Minimum 5 years PV experience with 2 years of additional experience with participation in pharmacovigilance and/or GCP audits/inspectionsSignificant pharmaceutical or health care related industry experience required.

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