Hobson Prior are looking for a Deputy EU QPPV to join a fantastic pharmaceutical organisation on a permanent basis with the ability to work remotely from anywhere in Germany, France, Italy and Spain. Our client is focused on high-quality, life improving generic pharmaceuticals.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for acting as single point of contact for EU competent authority on a 24-hour basis.
• Ensuring the structure and performance of pharmacovigilance system is in compliance with applicable directives and current EU good pharmacovigilance practices modules.
• Provide expert inputs and review the pharmacovigilance procedures.
• Support the pharmacovigilance team for any queries related to pharmacovigilance as and when required.
• Maintain oversight of the quality systems.
• Maintaining system oversight and overview of the safety profiles of all the products.
• Maintaining oversight on continuous change in benefit risk profile of the product.
• Managing and monitoring the compliance of pharmacovigilance system including timely submission of ICSRs and PSURs.
• Review of risk management plans, periodic safety update reports and keep oversight on risk minimization measures which are in place for approved products.
• Review and sign off the protocols for post authorization safety studies.
• Review and sign off the pharmacovigilance system master file.
• Review and provide inputs in deviations, CAPAs, change controls.
• Training to staff for PV as required.
• Perform audit of PV function as required.

Key Skills:

• The ideal candidate will have strong problem-solving and attention to detail ability and skills.
• Strong planning and organising ability.
• Excellent communication skills and ability to engage with Senior Leaders within the company effectively.
• Excellent collaborator with strong customer and stakeholder management and interaction skills.
• Excellent working knowledge and ability of using Microsoft Office Suite, including presentation skills.
• Have the ability to work towards deadlines.
• Able to work well alone as well as part of a team.

Requirements:

• For this role, you are required to have a full University degree in relation to pharmacy, medicine, pharmaceutical chemistry and technology or biology.
• Suitable and demonstrated previous experience as a Qualified Person responsible for Pharmacovigilance within a multinational company environment.
• Experience in all areas of PV.
• Extensive pharmacovigilance and safety knowledge and practical experience in the Pharmaceutical / CRO industry.
• Demonstrable expert knowledge in EU PV legislation.

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.