Senior Safety Scientist

Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to high in complexity or which concern low to high complexity products. Additionally supports activities including generation, review, and presentation of aggregate safety data, mentoring of more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.

• Serves as a creator/contributor for signal detection and product safety scientist tasks.
• Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.
• Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
• Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)
• Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.
• Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.
• Prepare data for and actively participate in safety governance processes.
• As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator’s Brochure (IB), or Informed Consent Form (ICF)
• Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity, or which concern low to high complexity products.
• Advises clients on safety related issues.
• Supports training and mentoring of junior colleagues.
• Contributes to development of processes, tools and systems.
• Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.
• Participates in departmental initiatives; Serves as a subject matter expert in designated area.
• Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Frequent contacts with internal personnel and outside customer representatives.
  

• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences fields.
  
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
• 10 + years Pharmacovigilance experience
• Extensive signal detection and /safety risk management experience
• Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
• Extensive signal detection & management experience is a must.
• Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
• Working knowledge of MedDRA
• Excellent attention to detail, data interpretation and medical-scientific writing skills
• Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately Solid project management skills with the ability to manage multiple projects simultaneously and ability to redress issues proactively with limited management intervention
• Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise
• Excellent oral and written English language communication skills, including paraphrasing skills
• Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
• Working knowledge of Oracle Empirica.
• Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience
• Ability to work effectively within a team to attain a shared goal

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.