Pharmacovigilance Manager

Gold Group Ltd.
London (South)
£45000 - £60000 per annum + bonus + benefits
21 Sep 2016
20 Oct 2016
Contract Type
Job Title: Pharmacovigilance Manager Therapeutic Areas: Oncology Location: South East UK or Scotland or Home Based Pay: To be discussed upon application Job Type: Permanent, Full Time, UK office or Home Based Company: To be discussed upon application My client is a leading global CRO that provides full service drug delivery services to the pharmaceutical and Biotech Industries, with a fantastic reputation a solid pipeline of new business this is an exciting time to further develop and enhance your career. Description With safety concerns becoming increasingly common among doctors and patients, having robust and accurate data helps us gain the trust of our customers. Our Safety and Pharmacovigilance service has been one of our core offerings since the ealy 90'2. They have a global team of experts who can support their customers across all phases of clinical trials and post marketing surveillance ensuring timely collection, analysis and reporting of safety data according to each company's regulations. To strengthen this group my client are seeking a Manager to be responsible for a team of Safety Specialists to be based in within the UK offices or from working at home Core responsibilities: A brief summary of duties you will be involved in as a Manager, Safety/Pharmacovigilance: Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, job description preparation, time sheet approval, and employee counseling. Assigning project work and reviews workload for all direct reports. Providing oversight and guidance on organizational goals and company objectives. Monitoring quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discussing below-target project goals with Associate Director / Director / VP. Managing projects where Safety and Pharmacovigilance are the primary services: Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. Works with Finance to ensure appropriate customer invoicing, where required. Approves project time cards and invoicing. Provides sponsors with scheduled project updates and reports. Participates in the management of the Safety and Pharmacovigilance department with the following actions: Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) or ensures compliance with sponsor SOPs. Ensures the execution of the Safety Management Plan/Safety Reporting Plan. Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. Works with Business Development to actively solicit new business, as needed. Reviews, advises, and approves drug safety portions of project proposals to ensure wording adequately reflects the scope of work for drug safety. Reviews and approves clinical safety sections of study protocols and Case Report Forms (CRFs). Approves budget projections for the project. Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process. Qualifications Skills and attributes: BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree. Moderate clinical research/drug safety experience or an equivalent combination of education and experience. Progressive responsibility with demonstrated leadership skills. Clinical Research Organization (CRO) experience with therapeutic specialties preferred. Working knowledge of financial budgets and various financial analysis tools preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and internet. This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview. This job was originally posted as