Pharmacovigilance Project Manager
On-site · Sao Paulo, São Paulo, Federative Republic of Brazil
Job Summary
Lead pharmacovigilance projects across clinical trials and post-marketing studies. Coordinate pharmacovigilance and drug safety delivery, resolve issues, and develop team capability. Develop and implement project plans with timelines, budgets, and resource allocation; ensure regulatory compliance and company standards. Coordinate with clinical, regulatory, and data management teams to ensure integration and execution of safety monitoring activities. Oversee collection, evaluation, and reporting of adverse events with timely submissions to regulatory authorities and sponsors. Provide strategic guidance and leadership to pharmacovigilance teams, including mentoring and training staff to enhance project performance and compliance. Monitor project progress, identify risks, and implement mitigation strategies to address issues that may impact project success.
Required Qualifications
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in pharmacovigilance or drug safety
- Strong understanding of safety reporting and regulatory requirements
- Proven project management skills
- Experience leading cross-functional teams
- Excellent organizational and analytical skills
- Strong communication and interpersonal skills
- Ability to collaborate with diverse stakeholders to drive project success
Additional Requirements
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
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