Pharmacovigilance Specialist

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

• 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

• Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures

• 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.

• Preparation of Standard Response letters, including conducting literature search, article summary etc.

• Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.

• Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to the EudraVigilance database (EV Web application or Gateway) and other regulatory authorities.

• Submits safety reports to licensing partners of PRA clients.

• Supports set-up of literature surveillance procedures, conduct of global and local literature searches, resourcing and general oversight for assigned projects.

• 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.

What ICON can offer you:

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At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people,patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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