Pharmacovigilance Specialist

Pharmacovigilance Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Signal detection and management:

• Safety monitoring using dedicated tools (e.g. Spotfire, Empirica Signals, as applicable) for signal detection purposes.
• Reviewing and assessing clinical and safety database outputs; analyzing and interpreting aggregate safety data from clinical trials and post-marketing sources and coordinating/supervising follow-up activities for important missing data elements.
• Reviewing the scientific literature (non-ICSR literature) for safety surveillance and signal detection purposes
• Analyzing safety signals (including authoring the signal evaluation report, and delivering relevant meeting contributions)
• Contributing to the development of Emerging Safety Issue Reports and respective communication to external stakeholders

RMP (updates) and periodic safety reports and response to HA questions

• Retrieve/summarize data
• Deliver content related input into RMPs (e.g. as document author)
• Support the local adaption of RMPs
• Deliver content related input into documents such as, but not limited to, periodic safety reports (e.g. as document author and/or managing contributions)
• Support analysis of the safety profile including the definition of important risks/safety concerns
• Prepare responses to HA questions related to RMPs or periodic safety report

Submissions and Safety Variations

• Provide input into safety documents of the CTD
• Provide contributions to ISS/SCS IAP, HA briefing documents, Modules 2.7.4 and 2.5, RMP and product information
• Provide content related safety input into Clinical Overview Addendum
• Prepare responses to HA questions related to Submissions and Safety Variations

Clinical trial activities

• Provide content related input into the safety sections of the IMPD, IB and ICF
• Provide safety related input into the development of other clinical trial related documents such as clinical trial protocols, search strategies for the integrated analysis plan clinical trial reports, clinical trial database set up
• Provide safety related input for data monitoring committees (i.e. charters, meeting minutes)
• Prepare responses to HA questions related to clinical trial (application)s

Other activities

• Participate in audits/inspections for areas of responsibility
  • Contribute to the design and implementation of post-authorization safety studies
  • Support Due Diligence programs with preliminary safety assessment
  • Develop and maintain MedDRA CMQs for the analysis of potential signals and aggregate safety data
• Develop product-specific trainings for internal or external stakeholders
• Provide expert input into the standardization and improvement of processes

Education:

• MD, or PhD/advanced science degree or tertiary level qualifications in a biomedical/health related field.
• Fluent in written and spoken English.

Necessary professional experience

• Pharmaceutical industry experience (≥ 3 years) in an R&D role (e.g. PV, clinical development, medical affairs, RA)  or similar external experience (e.g. Health Authority, research organization);
• Prior Pharmacovigilance experience preferred
• Experience working in cross-functional, global teams, across different regions preferred.
• Experience required in Scientific Literature review of Non-ICSR Literature
• Signal Detection experience is required.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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.

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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply