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Global PV Compliance & Training Manager

The Role

Global PV Compliance & Training Manager - Pharma Company - Hertfordshire - Competitive salary

**This company will interview, offer and onboard remotely**

 

The Company

An exciting opportunity with a leading integrated research-based, global pharmaceutical company, with 15 manufacturing facilities and 3 R&D centres dedicated to the goal of enriching lives across the globe. They have a rich pipeline of innovative molecules in various phases of development which are targeted in areas of oncology, respiratory and dermatology.

 

The Role

This company have currently an opening for an experienced pharmacovigilance professional to join them as a PV Compliance Manager. The role will be managing all global compliance activities as well as the oversight of training for the Pharmacovigilance function.

  • Manage and mentor global compliance and training staff reporting into the position
  • Review and track all PV and regulatory commitments and ensure all CAPAs are appropriately addressed and implemented in a timely manner.
  • Identify key PV risks and support the implementation of PV quality risk mitigation plans where appropriate.
  • Perform risk assessments on PV issues and audit findings to determine the need for CAPAs.
  • Participate in PV inspections and audits and facilitate inspection readiness activities as well as follow up post inspection compliance
  • Develop or review relevant GxP SOPs governing PV activities as well as other functional compliance area activities.
  • Coordinate, Implement and maintain the Pharmacovigilance System Master File (PSMF), mainly in Europe with support of regional PV leads regarding global PSMF requests.

 

You

  • Life science graduate, pharmacist, qualified nurse, other health care professional.
  • Minimum of 6-8 years related experience in a biotechnology or pharmaceutical company and/or CRO environment.
  • Minimum of 4 years' experience in Pharmacovigilance and quality assurance in tactical, operational and strategic capacities
  • Experience in CAPA Management, audit, and inspection support
  • Managerial experience

 

What should you do next?

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Consultant

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Claire Craig

Which team and area do you work/specialise in?

Clinical Operations as part of the Drug Development team

What are some of the typical roles you cover?

  • Senior and Clinical Research Associates
  • Clinical Trial Administrators
  • Research Nurses/Advisors
  • Patient Recruitment Roles
  • Study Start up roles

What are the hot issues in your sector currently?

Brexit, unsure if regulations etc will change within Clinical Trials

What’s makes you #DistinctlyDifferent?

Building relationships with my clients and candidates that are different to what they have had before. Consistent contact throughout the entire process. It works well and shows in results.

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