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Niche pharmacovigilance skillset reduces applicant competition.
Requires pharmacovigilance and regulatory experience specific to pharmaceuticals, limiting cross-industry transferability.
Explicit years by degree, regulatory expertise, and safety certifications increase filtering.
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Lead and manage global or regional drug safety projects ensuring all adverse event reporting meets regulatory and client timelines and standards.
Oversee processing, review, and quality assurance of adverse event data including expedited safety reports and safety databases for assigned projects.
Manage client communications, project deliverables, safety committee coordination, training, and audits related to pharmacovigilance projects.
Minimum 4-5 years safety experience with BS/BA; alternative education and experience options provided (e.g., Associate degree + 5-6 yrs safety experience, PharmD + 1-3 yrs safety experience).
Strong knowledge of global pharmacovigilance regulations, GCP, ICH guidelines, medical/drug terminology, and safety database operations.
Experience processing AE/SAE reports, coding, narrative writing, expedited reporting, and regulatory submissions.
Travel up to 10-15% required.
Experienced in managing pharmacovigilance operations within pharmaceutical, biotechnology, or CRO environments, including compliance with client and global regulatory standards.
Capable of overseeing complex safety databases, signal detection, and advanced safety reporting processes across multiple projects.
Demonstrates leadership in project management, client interaction, training, financial oversight, and audit preparation related to drug safety.