Senior Director, Pharmacovigilance & Risk Management

Recruiter
ProClinical Limited
Location
High Wycombe
Posted
09 Aug 2018
Closes
30 Aug 2018
Sector
Accountancy
ProClinical is seeking a Senior Director, Pharmacovigilance & Risk Management to be based in Buckinghamshire on a permanent basis. Successful candidates will be responsible for leading Global Safety Team(s) which are responsible for ensuring the safety of patients treated with the Company's products. The Senior Director will play a key role in the identification and execution of safety strategies to ensure successful development, and progression to market approval, for new drug entities in North America and the EU, whilst considering the needs of Japan and Asia. The successful candidates will be part of a new, virtual pharmacovigilance organisation led by the VP Pharmacovigilance and Western PV Head who is based in Galashiels, Scotland. The new position offers significant opportunities within the wider company group. Job Responsibilities: Leading Global Safety Team(s) to develop safety strategies for the meeting of Company targets and ensuring patient safety and regulatory compliance including for products that are in development and / or marketing. Providing medical analyses and input to meet international regulatory requirements and Company's objectives. Supporting the VP Pharmacovigilance in increasing the department's effectiveness and profile within the company and wider group. Supporting the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the company's Pharmacovigilance System. Determine the safety strategy for the preparation of regulatory submissions for new Marketing Authorisation Approvals in EAA and USA and ensure the delivery of high quality safety documentation for those submissions. Lead the preparation of Benefit Risk Assessments for company products and provide appropriate support for implementation of the associated conclusions. Developing proactive risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate strategies including Risk Management Plans. Ensure success of such activities by close liaison with Submission teams. Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, support of Company Core Data Sheets and other similar reports and actions. Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and post marketing purposes. Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of company products, safety issue works up etc. Ensure that updated safety profiles of company products are provided to senior management as required. Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed. Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department. Participate, when requested, in due diligence ensuring clear recommendations for progression to agreement Ensure that Ethics and Medical Compliance is applied within all pharmacovigilance activities To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team Any other activity that may reasonably be required. Skills and Requirements: You will be an experienced drug safety professional with excellent communication skills and the ability to proactively prioritise and manage multiple projects. With a strong focus on key deliverables, you will use your analytical skills to present complex data in an accurate and understandable manner. Medically qualified physician with post-registration clinical experience and extensive experience within pharmacovigilance or related area of clinical development. Knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post approval environments is desirable Fluent in English Excellent verbal, written, interpersonal, influencing and communication skills with emphasis on building consensus Ability to produce high quality, accurate work (oral written and presentation) to meet deadlines. Demonstrable managerial skills and leadership potential Well-developed analytical skills so as to present complex data in an accurate and understandable manner. Responsible, flexible and accountable with proactive approach. 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. This job was originally posted as www.totaljobs.com/job/82400449

Similar jobs

More searches like this

Similar jobs