Compliance Principal (QPPV & PV Excellence)

Employer
Hobson Prior
Location
Cheshire, England, Macclesfield
Salary
£450 - £500 per day
Closing date
22 Sep 2020
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Hobson Prior are looking for a Compliance Principal (QPPV & PV Excellence) to join a leading biopharmaceutical organisation who provide pioneering medicines to patients all over the world. As a Compliance Principal (QPPV & PV Excellence) you will take accountability for the management of assigned projects and partnerships.

Job Responsibilities:

  • You will drive a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches, across the organisation's Pharmacovigilance system.
  • Recognise opportunities to improve and simplify processes and guidance, provide practical solutions and drive implementation.
  • Accountable to develop and improve reporting tools and analysis processes and technology.
  • Working with Patient Safety Process and Partnerships Leads and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to pharmacovigilance data reporting.
  • Support activities for GVP, GCP and GMP audits/inspections both globally and with local affiliates.
  • Provide training to CMO and other functional groups in key areas of expertise.
  • Provide support to outsourcing partners to facilitate compliance with regulatory and legal requirements and maintain inspection readiness.
  • Contribute to communication and change management activities associated with CMO initiatives.
  • Manage relationships/partnerships/alliances external to the CMO function.
  • Working collaboratively, provide expertise and sharing best practices across all regions and in all partnerships.
  • Monitor, interpret and validate current, new and changing legislation and manage the impact of changes.
  • Use deep understanding of pharmacovigilance processes and regulations provide compliance support to safety and regulatory teams and submissions.
  • Serve as the delegate, where appropriate, for the CIR Leads.
  • Ensure that appropriate, up-to-date records are maintained for compliance.

Key Skills:

  • Proven ability to work cross-functionally, across cultures and time zones in a virtual/remote environment.
  • Leadership skills, including experience of leading project teams.
  • Problem solving and negotiations skills.
  • Good attention to detail.
  • Excellent written and verbal communication skills.

Requirements:

  • A science/pharmacy/nursing degree.
  • A minimum of 5 years relevant experience (pharmaceutical, regulatory, safety and partnership).
  • In-depth scientific knowledge sufficient to understand all aspects pharmacovigilance issues
  • In-depth knowledge of the drug development process.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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