Sr. Manager of Pharmacovigilance

Senior Manager of Pharmacovigilance - Oncology - Home Based (US)

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.

The Senior Manager of Pharmacovigilance will be responsible for the execution of global pharmacovigilance activities supporting late-stage clinical development and preparation for first commercial launch of small-molecule oncology products in lung and prostate cancer. This role will ensure compliance with global safety regulations and will work closely with cross-functional partners to ensure individual case safety report (ICSR) processing, Health Authority submissions, and post-marketing safety readiness.

This is a hands-on role well suited for a biotech environment requiring both operational excellence and cross-functional collaboration.

Job Description

Global Drug Safety & Pharmacovigilance Operations

• Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products

• In partnership with Clinical Research Organizations (CROs), oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines

• Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners

• Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)

• Develop, maintain and execute Safety Management Plans for clinical studies

Clinical Development & Regulatory Affairs Support

• Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable)

• Review clinical trial safety data and assist with data cleaning for ongoing studies

• Participate in periodic safety reviews, signal detection and risk evaluation activities

• Maintain Reference Safety Information for the client's products and co-administered IMPs

• Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)

• Assist with preparation for regulatory inspections and audits

Cross-Functional Collaboration

• Participate in internal Safety Management Teams and governance meetings

• Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams

• Support safety training for internal stakeholders and investigators

Vendor & Compliance Oversight

• Support oversight of pharmacovigilance vendors and service providers

• Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained

• Assist in development and maintenance of SOPs and training materials

Required Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology

• 12 years’ pharmacovigilance experience with Bachelor's degree -or- 8 years’ experience and Master's degree -or- 5 years’ experience and PhD-including clinical trial and/or post-marketing experience

• Experience with small-molecule oncology products

• Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS)

• Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases

Preferred Qualifications

• Oncology experience in lung and/or prostate cancer

• Experience in biotech/ small pharmaceutical company or CRO environments

• Experience supporting NDA/MAA submissions and commercial launch

• Familiarity with REMS, RMPs, and post-marketing commitments

Skills and Attributes

• Strong strategic thinking combined with a hands-on, execution-focused mindset

• Proven ability to collaborate and lead in a cross-functional, matrixed organization

• Excellent written and verbal communication skills, with the ability to convey complex data clearly

• Highly organized, adaptable, and comfortable working in a fast-paced, evolving environment

• Mission-driven, patient-focused, and committed to scientific integrity

• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

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