Head of Pharmacovigilance

Proclinical is currently seeking a Head of Pharmacovigilance for a global Pharmaceuticals company. This is a newly created role, and as the Head of Clinical Safety, you will have the opportunity to shape, develop and grow the Pharmacovigilance department while contributing to the growth of the wider business. You will be responsible for global pharmacovigilance benefit-risk and surveillance activities across the entire portfolio, in addition to providing leadership and direction to the team. You will also ensure compliance with international pharmacovigilance regulatory requirements is maintained while delivering on the company strategy

Job Responsibilities:

• Reporting to the Chief Medical Officer build and lead the pharmacovigilance department and be accountable for all safety related deliverables including but not limited to the Risk Management Plans, safety sections of labelling documents, investigator brochures, relevant aspects of clinical study reports and submission dossiers.
• Provide operational and performance management for the department
• Oversee and guide the active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle for all assets
• Lead development and update of all core safety related documents such as Company Core Safety Information and Risk Management Plans.
• Lead the Pharmacovigilance Safety Review Teams
• Act as a key interface with other functions in the business and vendors
• Support Due Diligence activities as required.
• Ensure regulatory agency inspection findings and internal audit findings relating to signal detection, evaluation and risk mitigation are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively as required.
• Participate actively in the Continuous Improvement Process (CIP) targeted at continuous quality improvement of pharmacovigilance procedures and processes

Skills and Requirements:

• Solid experience in Benefit-Risk Management and Clinical Trial Safety is required, in all aspects of Benefit-Risk Management (risk identification; risk assessment; risk communication; risk mitigation; evaluation of risk mitigation)
• Exposure in Pharmacovigilance with broad overview of all aspects of a PV system and specific experience in signal detection and risk management
• Expert in the Safety Regulations with comprehensive knowledge of global drug safety regulations/ guidance's
• Familiarity with cross functional principles of drug development, pharmacology, biostatistics, clinical trial methodology, pharmacoepidemiology, medical safety and pharmacovigilance.
• Proficiency in problem-solving within a highly complex environment
• Strong communicator
• Good networking and team skills for successful cooperation with internal and external customers.
• Proven team leader/ manager
• Physician (MD) qualification

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.