Pharmacovigilance Project Manager
Core
Leading and overseeing pharmacovigilance activities for post-marketing projects and clinical trials, ensuring regulatory compliance and safety monitoring.
Role type
Senior IC pharmacovigilance project manager
Builds
Drug safety monitoring activities and regulatory submissions
Domain
Healthcare / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance and drug safety expertise, ANVISA regulation knowledge, project management, cross-functional team leadership, risk mitigation, PSMF maintenance
Preferred skills
Strategic guidance, mentoring, local regulatory interface management
Technologies
ANVISA regulatory systems
Responsibilities
Manage planning, execution, and delivery of PV projects; coordinate with clinical, regulatory, and data teams; oversee adverse event collection and reporting; maintain local PSMF; serve as local interface with global PV system and ANVISA.
Seniority
Senior, hands-on IC