PV Inspections Readiness Principal

Hobson Prior are looking for a PV Inspections Readiness Principal to join a top pharmaceutical organisation who establish standards, provide scientific solutions and lead innovation. This position will work in the QPPV & PV Excellence Team in Patient Safety Centre of Excellence where you will take responsibility for the management of the organisation's 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 PV system.
• Accountable to recognise opportunities to improve and simplify processes and guidance, provide practical solutions and drive implementation.
• Partake in and/or support activities for GVP, GCP and GMP audits/inspections both globally and with local affiliates.
• Utilise knowledge of pharmacovigilance and associated regulatory and drug development processes to maintain and support the global inspection readiness strategy.
• Working across CMO, identify issues and risks and propose options to mitigate them.
• Working across CMO, support RCA and CAPA development and monitor completion.
• Deliver 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.
• Working collaboratively, provide expertise and sharing best practices across all regions and in all partnerships.
• Any other assigned tasks.

Key Skills:

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

Requirements:

• A science/pharmacy/nursing degree.
• At least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership).
• Thorough 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.