ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
- Provides medical expertise on clinical drug development throughout life-cycle of compound:
- Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
- Provides continuous medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study.
- Provides therapeutic training relevant to specific study to the project team.
- Attends and/or presents at investigator, internal and external project team meetings.
- Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken. Assumes responsibility for ethical, e.g. medical, aspects of study.
- Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
- Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
- Assists the clinical team in selection and recruitment of investigational sites.
- Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization:
- Evaluates and assesses serious adverse events.
- Generates and/or reviews notification letters to health authorities, investigators, IRBs and Ethic Committees.
- Reviews, analyses and summarizes data for Data Monitoring Committees.
- Contributes to and reviews Aggregate Safety Reports, evaluates benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options.
- Contributes to and reviews Safety Management Plans, Signal Detection Plans, Pharmacovigilance Plans, Risk Management Plans including design and conduct of safety studies.
- Provides benefit/risk evaluations and drug safety expertise for marketed drugs, diagnostics, and devices: Evaluates spontaneous reports and literature cases.
- Provides individual and cumulative benefit/risk assessments.
- Communicates with reporting health care professionals, experts and consumers. Reviews and authorizes Periodic Safety Update Reports.
- Evaluates safety issues. Recommends interventions to client.
- Contributes to hearings at regulatory agencies and/or court. Supports generation of publications and expert reports:
- Reviews and interprets study results and clinical study reports.
- Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations.
Supports Business Development (BD):
- Builds relationships with new customers, maintains client relationships to obtain repeat business. Identifies new business opportunities through contacts, literature, and conferences.
- Promotes PRA through active involvement in scientific meetings and speaking engagements.
- Contributes to RFPs by identifying critical success factors and providing options for different approaches for patient recruitment, referral systems, and operational execution.
- Attends bid defense meetings including generating presentations and, takes active role in RFP discussions with clients.
- Supports BD in client contacts to discuss portfolio and development strategies.
IF APPLICABLE:
Responsibilities as EU Qualified Person responsible for Pharmacovigilance (EU QPPV):
- With the marketing authorization application the marketing authorization holder (MAH) must provide evidence that the services of an EU Qualified Person responsible for Pharmacovigilance (EU QPPV) is in place. MDs residing in one of the EMA member states and adequately trained and qualified in all aspects of
- Pharmacovigilance might assume responsibility for the MAH’s pharmacovigilance system. Specific responsibilities of the EU QPPV or EU QPPV deputy may include:
- Reviews and approves the Pharmacovigilance Master File (PSMF) and implements changes to PV processes.
- Ensures compliance and timely submission of Individual Case Safety Reports (ICSRs).
- Reviews Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs) to ensure compliance and timely submission:
- Contact person for any agency questions or requests.
- Determines the most appropriate person to sign the PBRER/PSUR. Reviews and gives input for signal detection plans and activities
- Reviews and provides input for European Risk Management Plan (EU-RMP).
- Provides input to Investigator Brochure (IB)/Summary of Product Characteristics (SmPC)/Product Information/Labelling and safety variations.
- Is involved in the preparation and conduct of any pharmacovigilance audits or inspections (incl. review of audit and inspection reports.
- Reviews and gives input to training plans for staff members (PRA or client) who can be involved with receipt, processing and submission of ICSRs.
- Is involved in review and sign-off of protocols of post-authorization safety studies conducted in EU.
- Ensures conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and Good Pharmacovigilance Practice (GVP).
- Ensures necessary quality (incl. correctness and completeness) of pharmacovigilance data submitted to the competent authorities in Member States and the Agency.
- Ensures a full and prompt response to requests from the competent authorities in Member States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
- Provides any other information relevant to the benefit-risk evaluation to the competent authorities in Member States and the Agency;
- Provides input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
- Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the
- Agency and for pharmacovigilance inspections as per legal requirements. Assume primary medical monitoring responsibilities on global projects:
- Leads and drives processes and solve problems, both, internally and towards clients on global projects.
- Leads discussions with clients related to details on project set-up and conduct, as well as potential scientific misconduct.
- Provides oversight of the generation of project plans such as Safety and Medical Management plans (SMMP) in close cooperation with project team during set-up phase.
- Develops and implements training for project team members
- Serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader; serves as a mentor/expert for new employees.
APPLIED KNOWLEDGE SKILLS:
- Applies process, systems effectively.
- Demonstrated application of presentation and communication skills. Expert in PRA processes and systems.
- Able to effectively mentor new staff.
PROBLEM SOLVING FACT FINDING ANALYSYS:
- Able to judge and challenge information.
- Solves routine issues.
- Thinks effectively outside the box.
- Tailors argument to level, experience and needs of audience.
- Effective and convincing at bid defenses
IMPACT:
- Failure to adequately monitor and manage medical monitoring activities of associated clinical trial(s) could result
- in failure to meet deliverables, critical delays and budget impacts and/or breach of contract.
SUPERVISION GIVEN/RECEIVED:
- Works under general supervision.
- May seek assistance to resolve more complex and difficult issues. Work is reviewed throughout the project involvement for soundness, judgment and adequacy.
- Licensed physician
- 3 years of experience writing pharmaceutical or health-related documents. Good communications and presentation skills.
- Experience using computerized systems (PC-Windows and MS Office).
- Clinical practice and/or clinical research or drug safety experience.
- Broad knowledge of regulatory requirements.
- Read, write, and speak fluent English; fluent in host country language.
- Good project management skills.
- Experience in mentoring more junior team members.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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