Sr. Manager of Pharmacovigilance

ICON plc • Blue Bell, SD

2d • Remote

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to היו patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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.

Requirements

• 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
• 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
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• 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

Responsibilities

• 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
• 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
• 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

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior