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

Job title: Experienced Senior Manager of Pharmacovigilance - Oncology - Home Based (US)

About the Role The Experienced 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 ensures compliance with global safety regulations and will work closely with cross-functional partners to ensure ICSR processing, Health Authority submissions, and post-marketing safety readiness. This is a hands-on role well suited for a biotech environment requiring operational excellence and cross-functional collaboration.

What You'll Do

• 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.
• 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.
• 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; Provide training for internal stakeholders and investigators.

What We're Looking For

• 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 (FDA, EMA, Health Canada, and Asian Health Authorities such as Japan PMDA, South Korea MFDS).
• Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases.
• Must be legally authorized to work in the United States without sponsorship (per company policy); visa sponsorship not available.
• Preferred qualifications include oncology experience in lung and/or prostate cancer; experience in biotech/small pharma or CRO environments; experience supporting NDA/MAA submissions and commercial launch; familiarity with REMS, RMPs, and post-marketing commitments.

Nice to Have

• 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.

Compensation & Benefits

• Competitive salary and range of benefits designed to be competitive within each country.
• Various annual leave entitlements and health insurance offerings.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme LifeWorks (24-hour access to global network of professionals).
• Life assurance and flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, etc.).
• ICON is committed to inclusion and belonging and provides an accessible environment for all candidates.