Associate Director, Medical Information

Company: Ergomed Plc
Location: Cary
Posted on: February 23, 2021

Job Description:

PrimeVigilance, an Ergomed brand , was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects. Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.-- Job Description This position provides senior management of medical information operations in PrimeVigilance. The tasks are performed in line with global and functional objectives provided by Senior Vice President/GM, and Executive Management. Ensures that Medical Information activities are conducted in compliance with applicable regulations, regional and local guidelines and standards, in particular; The Rules Governing Medicinal Products in the EU; ABPI Code of Conduct and PrimeVigilance Quality Management System. The Associate Director, Medical Information educates, mentors and develops her/his direct reports. KEY RESPONSIBILITIES Ensures the MI Managers and Seniors deliver contracted work in line with the applicable contracts, agreements and quality requirements; Supervises quality, compliance and performance metrics related to MI processes and communicates with clients as necessary about the results; Serves in the escalation chains as per applicable procedures; Oversees MI service provided to clients; Oversees client satisfaction and takes measures to rectify client dissatisfaction, as appropriate; Schedule and facilitate service review meetings with clients as agreed and contracted; Oversee client CAPAs raised in medical information and ensure the timely update and completion of all CAPAs. Training and development of skills of MI Managers reporting to Head of MI Operations; Ongoing and periodic appraisal of direct reports; Keep her/his knowledge and skills in the area of MI up-to-date and in line with her/his training plan. Qualifications Extensive applicable pharmaceutical and/or biotech medical information and pharmacovigilance experience; GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines; Product Knowledge: Understands the medical/therapeutic impact of products; Scientific Knowledge: Possesses the necessary science education and knowledge to manage operations; Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines; Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organised and a timely manner and proactively communicate changes in pre-established goals and deadlines; Willingness to travel to various meetings or client sites, including overnight trips. International travel is occasionally required. Education -- University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master degree in a scientific discipline, or equivalent advanced degree with experience; Experience Extensive in medical information, demonstrated experience--in a managerial role within medical information. Additional Information All your information will be kept confidential according to EEO guidelines. Our Offer:

• Work within a successful, highly - qualified and dynamic team
• Professional training and career development in a fast-growing healthcare company

Keywords: Ergomed Plc, Elgin , Associate Director, Medical Information, Healthcare , Cary, Illinois