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 1992. We have a global team of experts who can support our 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 INC are seeking a Manager to be responsible for a team of Safety Specialists to be based in Poland, Warsaw.
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.
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. Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills. Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment. Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don't worry - if you've got the passion part, we'll help you develop the skills you need to enhance every aspect of your career in the clinical research industry. We've got an attitude at INC: "Can do, I own it." Absolutely everyone has ownership of what they do here. And because we're given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too. "INC Research has been ranked as "Top CRO to work with" among large global CROs in the biannual CenterWatch Global Investigative Site Relationship Survey. INC is the only CRO to rank consistently among the top three CROs in all seven CenterWatch site relationship surveys conducted since 2007".
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.