EU QPPV

Hobson Prior are currently looking for an EU Qualified Person for Pharmacovigilance to join a leading biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world. You will be responsible for establishing, maintaining, and managing the Marketing Authorisation Holder's (MAH's) pharmacovigilance (PhV) system.

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

Key Responsibilities:

• Acts as a single contact point for PhV for the EU Competent Authorities, the UK authority and European Medicines Agency (EMA) on a 24/7 basis and as contact point for PhV inspections in the EU/EEA and the UK.
• Serves as the QPPV in the EU, residing in the EU/European Economic Area (EEA), and fulfils the role of QPPV EU as defined in the current legislation and guidance's.
• Serves as the QPPV in the UK, residing in the EU/European Economic Area (EEA), and fulfils the role of QPPV UK as defined in the current legislation and guidance's.
• Maintains an overview of the safety profiles and emerging safety concerns of the company's products with a marketing authorization application (MAA) or a marketing authorization (MA) in the EU/EEA and the UK, through:
• Active involvement in risk management and evaluation activities through either attendance at or receipt of agendas and minutes for Safety Review Committee meetings, Safety Review Board meetings, core labelling review meetings, and joint safety review meetings with business partners (as appropriate).
• Review and approval of regulatory communications, analyses, or reports for product(s) with an MAA or MA in the EU/EEA and the UK, including, but not limited to, aggregate reports such as Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), and EU Risk Management Plans (RMPs).
• Maintains oversight of the pharmacovigilance system applicable to products with an MAA or MA in the EU/EEA or UK, through:
• Review and provision of input to PhV policies and procedures, including business continuity plans and interdepartmental or other functional area SOPs, as appropriate.
• Review and approval of the pharmacovigilance system master file (PSMF).
• Review of applicable performance measures for PhV (including applicable PhV vendor activities) the PhV audit program, PhV-relevant audit reports and corrective and preventive action (CAPA) plans.
• Any other assigned duties.

Key Skills:

• Ability to communicate effectively (cross-functionally and within the function) to create a positive and productive working environment.

Requirements:

• Medical physician (M.D. or equivalent) with a minimum of seven (7) years' experience in the pharmaceutical/biotechnology industry in pharmacovigilance/drug safety.
• Experience in conducting individual case reviews for expedited safety reporting.
• Experience analysing clinical case series for the purposes of aggregate safety reporting, signal detection, issue management, and responding to queries by regulatory authorities for both clinical and post marketing products.
• Experience as an active contributor to EU submission dossier (Clinical Study Reports (CSRs), Clinical Overview, Renewal).
• Post-graduate clinical experience in academic or private practice including a hospital-based setting, preferably in oncology.
• Prior experience as EU QPPV for a pharmaceutical or biotechnology company with active clinical research and development.
• Experience in developing and executing risk management strategies (e.g., Risk Management Plans, risk minimization measures, monitoring of adverse events of special interests).
• In-depth knowledge of Good Clinical Practice and Good Pharmacovigilance Practice.
• Excellent understanding of drug development and life-cycle management of medicinal products.
• Advanced knowledge of pre-and post-marketing US, EMA, and worldwide safety regulations.
• Fluent in written and spoken English.
• Ability to travel as needed.

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.