My client, a global Healthcare provider are looking for a PV Manager to be based at their site in the East Midlands. It's a great opportunity to join a growing business that has seen huge investment over the last few years.
Title: PV manager
* Responsible client stakeholder engagement, knowing each client's task and managing expectations and deliverables
* Continuously works with internal and external clients to ensure satisfaction ensuring that their requirements and expectations are understood and professionally managed.
* Conduct compliance meetings with clients
* For pharmacovigilance matters: Serves as deputy to Director of Regulatory affairs and PV
* Ensures effective functioning of all PV projects in compliance with client agreement, contract; and local and global regulatory guidelines
* Escalation in the event of problems relating to internal staff workload that may affect the quality and functioning of the tasks being undertaken.
* Oversight of source data verification (SDV) activities, deviations and reconciliation
* Ensure that all reports/metrics around PV are collated and communicated to appropriate parties promoting companywide compliance and best practice.
· Minimum of 2 of pharmacovigilance and/or industry experience
· Knowledge of regulatory requirements pertaining to Pharmacovigilance in the pre and post approval environments
· A good understanding of clinical quality assurance
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