At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Roles & Responsibilities:

Ensures accuracy and consistency of safety data processing from receipt from various sources to final output (e.g. reports, listings, data export).

. Expertise in working with Argus safety database

. Experience working with post-marketing projects  and support the client and company in product launches with good knowledge of global health authority regulations especially USFDA with regards to post marking event processing and reporting..

Experience in working in clinical trial projects in Argus database
• Conducts and participates in review and quality control of contracted deliverables, ensuring that outputs meet expectations and are consistent with the processes described in the respective planning document.
• Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
• Reviews and processes literature based ICSRs identified from articles.
• Provide input and review of relevant safety tracking systems for accuracy and quality and assist with maintaining project files
• Perform safety review of clinical and diagnostic data for case processing
• Assist with generation of regulatory reports as necessary to ensure regulatory compliance.
• Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues
•Supports the Pharmacovigilance management team with inputs regarding audits, inspections and business development activities.
• Develop, maintain, and document workflow processes and liaise with external departments, as needed
• Provides technical and process oversight with respect to safety services for interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities) and on assigned projects. Serves as primary escalation point for internal and external team members for risks associated with assigned services.
• Completes first line reviews of complex planning documents for the contracted services (e.g. Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans) and ensures consistency of those across assigned projects and service areas.
• Serve as Functional Lead on case processing or medical information projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.
• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
• Generates data listings from the safety database and assumes responsibility for accuracy of the data.
• Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).
• Supports Safety Scientist in signal detection and risk management activities.
• Supports interim data analysis for DMC reviews.
• Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.
• Ensures timely completion of internal and external status reporting, metrics, and key performance indicators for the assigned services
• Identifies operational and/or financial risks in relation to the assigned services and escalates those to the responsible functional and/or project manager(s)
• Supports the department management team in the development of training courses as well as SOPs and associated documents.
• Conducts service area specific safety training sessions for assigned team members and serves as lead mentor for less experienced staff.
• Proposes solutions for procedural and technical issues.
• Supports audits and inspections as required for the assigned service area and/or projects.
• Perform other activities as identified and requested by management including but not limited to:
• Respond and process medical information inquiries, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
• Supports business development activities by reviewing safety section of proposals and attending sponsor bid defense meetings.
• Is involved in creation and revision of Pharmacovigilance related manuals and process documents
• Acts as Subject Matter Expert in departmental initiatives.

For ICON Strategic Solutions:
• Submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during project set-up, within project specified timelines..
• Serve as support to the PV processing management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
• Work within multiple databases. Maintenance of project information with timely updates to the project databases.
• Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
• Perform or Supervise periodic reconciliation of adverse event and/or quality complaint cases within the required deadlines.
• Submits safety reports to licensing partners of ICON clients.
• Coding Adverse Events in accordance to the applicable standard dictionary
• Perform or Supervise quality complaint activities for assigned projects
• Quality Control of activity as applicable

• Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with ca se processing

Provides technical and process oversight with respect to safety case processing services on assignments. 
• Perform oversight of assigned projects or portfolio ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information

Operate in a lead capacity ensuring ownership and accountability of case processing activities on assigned projects

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