Associate Director, Medical Information
Company: Ergomed Plc
Location: Cary
Posted on: February 23, 2021
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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:
Keywords: Ergomed Plc, Elgin , Associate Director, Medical Information, Healthcare , Cary, Illinois
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