Deputy Head International Safety & Deputy EU QPPV

Proclinical is working with a leading biotechnology company that is seeking a Deputy Head International Safety & Deputy EU QPPV to be based in Europe on a permanent basis. Support implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management, and communication of safety information. Serve as expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product's drug safety profile.

Job Responsibilities:

• Together with the EU QPPV serve as the principal safety contact with European and Ex-USA ROW regulatory agencies
• Ensure development and implementation of department policies and strategies in collaboration with the EU QPPV and the Global Head, Drug Safety and the department management team, consistent with regulatory requirements and industry best practices.
• Oversee preparation, finalization, and execution of Pharmacovigilance agreements
• Ensure that all Pharmacovigilance activities are carried out in a fully compliant manner in accordance with company policies and country laws and regulations
• Accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities and safety agreements with corporate partners.
• Serve as resource for the company and Vendor personnel handling adverse events including, but not limited to: data handling conventions, coding, medical review, causality assessments, advice regarding reportability
• Support, develop and monitor the Benefit risk profile of marketed products, ensure RMP implementation and compliance with the implementation, monitoring of the risk-benefit profile of the product throughout the life cycle activities for each program
• Back up EU QPPV/represent EU and ROW in the development of the core RMP and country-specific Risk Minimization Plans (RMP) for all assigned products
• Review and approve PSURs, DSURs, RMPs, Safety Signalling reports and PASS protocols and CSRs
• Support the development and advise on the creation and maintenance of company core safety information and safety language in local labelling
• Provide expert advice on medical matters in general, and specifically on safety-related issues concerning all company products during their product lifecycle, and phase IV trials.
• Keep informed of, and interpret the relevance and applicability of new safety regulations and guidance from the regulatory authorities in the territories ex-USA
• Attend the cross-functional Safety Monitoring Committee and the Quality PPV oversight Committee
• Keep upper management informed of special concerns and developing safety problems with all company products during their product lifecycle

Skills and Requirements:

• M.D Degree
• Minimum of 4 years of clinical experience as a practicing physician
• Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
• Minimum of 3 years' experience as EU QPPV
• Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
• Experience with pharmacovigilance audit and regulatory inspection processes.
• Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
• Familiarity with common adverse event management databases (e.g. Argus)
• Knowledge of MedDRA and WHO Drug coding dictionaries
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
• Excellent verbal and written communication skills, including formal presentations. Proficiency in Microsoft Excel, PowerPoint and Word required
• Sound organizational skills with the ability to prioritize tasks
• Excellent interpersonal, team management and leadership skills
• Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
• Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

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 Kevin Hansberry on +44 207 4400 636 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.