Drug Safety Coordinator(Sr.PV Associate)

As a (Drug Safety Coordinator- Sr. Pharmacovigilance Associate Position) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

Pharmacovigilance

<Interaction with Regional Safety Officer>

• Prepare the monthly report and notify it to the RSO
• Communicate with regional safety officer about any safety relevant issues (e.g. potential emerging safety issues, deviations, safety requests from HA, local regulatory updates, studies, organized data collection programs etc.)
• Report any changes to local pharmacovigilance regulations that may impact Eisai global pharmacovigilance activities to the RSO.

<QMS>

• Ensure the preparation or revision of local procedural documents
• Create appropriate systems to monitor compliance to local regulations and relevant procedural documents
• Ensure all pharmacovigilance activities comply with local regulations including provisions for privacy and security of personal medical information
• Perform audits and/or inspections and manage any findings

<Training>

• Arrange training of all appropriate staff and ensure all the trainings are conducted according to the Annual Training Plan

<Third parties management>

• Ensure a process is in place to appropriate oversight of all third party and partner agreement, including oversight of training for third party staff who could potentially receive AEs
• Based on the SADE or contracts with partner companies, the LSO ensures to conduct the reconciliation

<Case processing>

• Ensure all case processing is on track, both in terms of timelines and quality
• Ensure that local literature search is performed, and relevant cases are submitted
• Review local study protocols and assume responsibility for their AE/SAE reporting sections

<Regulatory communication>

• Monitor any changes to local pharmacovigilance regulations that may impact Eisai global pharmacovigilance activities
• Review all proposed local safety related package insert changes on whether it is compliant with the current company core data sheet (CCDS) at the timing of CCDS update.

<RMP>

• Create and maintain timeline for submission and approval of MFDS by communicating with other relevant functions (e.g., regulatory affairs, marketing department, etc.).
• Prepare local risk management plan (RMP) based on reference RMP (e.g., CCRMP, EURMP) and if there are any discrepancies between local RMP and reference RMP, escalate it to the regional safety officer
• Conduct trainings to relevant employees with RMP implementation including additional risk minimization activities
• Prepare and finalize periodic report monitoring adherence to the process of RMP implementation and timely submit it to MFDS within the timelines defined by local regulations

#LI-office

#LI-SO1

You are:

• 6-8 year(s) of PV (and RMP) working experience
• Preferred Pharmacist
• Fluent verbal and written English
• MS office skills
• Good communication skills
• Fixed Term Contract Position

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.