Manager, Pharmacovigilance
Overview
As a Manager of Pharmacovigilance, you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Manage DSA teams and oversee processing of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials to ensure high quality case reports and submissions compliance.
• Support DSA teams by assigning staff within case management lifecycle processes including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions.
• Oversee literature review and reporting teams and processes.
• Support the aggregate reporting and risk management teams.
• Support the QPPV and Senior Management as required.
• Assist with quality and compliance metric oversight and trend analysis, and assist with identification and correction of identified quality and compliance issues.
• Represent Pharmacovigilance on intradepartmental, business partners, and vendor teams.
• Provide in-depth technical expertise on Pharmacovigilance processes and systems.
• Oversee CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Support audit and inspection processes as required.
• Ensure compliance with Pharmacovigilance data reconciliation processes, and work to resolve/escalate issues as appropriate.
• Actively identify process improvement and efficiency needs and develop solutions as appropriate.
• Develop procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes.
• Assist in resource management processes, including line management of assigned staff and succession planning.
• Develop supporting staff skills, encourage growth and provide regular performance feedback.
• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
• Maintain files and systems as appropriate.
Qualifications
You are:
• Minimum of 6 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience, with an additional 1-2 years’ experience leading teams.
• Bachelor’s degree in a science or healthcare related discipline (nursing/pharmacy preferred)
• Safety database system expert (Argus required).
• Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Demonstrates accountability and responsibility for both management role and assigned team.
• Expert organizational, time management, and problem-solving skills.
• Proficiency with creating and delivering presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
• Travel (domestic and global) 10%.
• Ability to travel to office for monthly departmental meetings at assigned client offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.
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, 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, colour, 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.
Apply Now
Apply Now
As a Manager of Pharmacovigilance, you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Manage DSA teams and oversee processing of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials to ensure high quality case reports and submissions compliance.
• Support DSA teams by assigning staff within case management lifecycle processes including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions.
• Oversee literature review and reporting teams and processes.
• Support the aggregate reporting and risk management teams.
• Support the QPPV and Senior Management as required.
• Assist with quality and compliance metric oversight and trend analysis, and assist with identification and correction of identified quality and compliance issues.
• Represent Pharmacovigilance on intradepartmental, business partners, and vendor teams.
• Provide in-depth technical expertise on Pharmacovigilance processes and systems.
• Oversee CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Support audit and inspection processes as required.
• Ensure compliance with Pharmacovigilance data reconciliation processes, and work to resolve/escalate issues as appropriate.
• Actively identify process improvement and efficiency needs and develop solutions as appropriate.
• Develop procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes.
• Assist in resource management processes, including line management of assigned staff and succession planning.
• Develop supporting staff skills, encourage growth and provide regular performance feedback.
• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
• Maintain files and systems as appropriate.
Qualifications
You are:
• Minimum of 6 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience, with an additional 1-2 years’ experience leading teams.
• Bachelor’s degree in a science or healthcare related discipline (nursing/pharmacy preferred)
• Safety database system expert (Argus required).
• Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Demonstrates accountability and responsibility for both management role and assigned team.
• Expert organizational, time management, and problem-solving skills.
• Proficiency with creating and delivering presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
• Travel (domestic and global) 10%.
• Ability to travel to office for monthly departmental meetings at assigned client offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.
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, 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, colour, 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.
Apply Now
Apply Now