This Global Risk Management & Safety Surveillance (GRMSS) Scientist collaborates with the GRMSS Physicians and GRMSS Scientists to characterize the evolving clinical and post-marketing safety profiles for investigational drugs and/or products, based on analysis of aggregate data sets from internal or external sources and the medical literature. This entails drafting, reviewing, and refining portions of periodic aggregate safety reports (including DSURs, PADERs/PAERs). The GRMSS Scientist performs the signal detection activities and review process for clinical data, including signal detection, evaluation, and verification; potential sources of data for signal detection include the sponsor, external marketing partners, or contracted business entities. The GRMSS Scientist in this position documents signal detection activities and communicates appropriate summaries to internal stakeholders and external partners.
What you will be doing:
- Support GRMSS Physicians and GRMSS Scientists and aid in the coordination and preparation of Safety Management Team meetings.
- Provide support as needed to the GRMSS Physicians in review of periodic literature for new and important information regarding products.
- In collaboration with the GRMSS Physicians/Scientists, support the preparation of Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs) and Periodic Adverse Experience Reports (PAERs) for clinical trial programs and marketed products.
- Participate in internal safety process improvements and updates.
- Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance by following standard operation procedures and processes.
- Provide overall support to the GRMSS Physicians and GRMSS Scientists for global risk management and safety surveillance activities.
- Two to four years of Pharmacovigilance/Drug Safety experience required.
- Experience analyzing safety case reports for the purposes of preparing aggregate safety reports (DSURs, PADERs), signal detection and evaluation, and responding to queries by regulatory authorities required.
- Experience incorporating safety findings into aggregate reports (DSURs, PADERs/PAERs) required.
- Fluency in written and spoken English.
- Experience in pharmaceutical industry activities involving health authorities outside the United States preferred.
- Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to clinical support of oncology, immunomodulatory, or other related products preferred.
- Healthcare degree (e.g., BSN, CRNP, Pharm.D.) preferred (or relevant scientific degree buttressed by industry experience).
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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
