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Pharmacovigilance niche reduces applicants, but metro location and common PM title increase competition.
Role requires domain-specific pharmacovigilance and regulatory knowledge, limiting cross-industry transferability.
Explicit years, regulatory/pharmacovigilance experience and SOP/compliance requirements create strict screening filters.
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Lead and manage global or regional drug safety projects ensuring compliance with international pharmacovigilance regulations and timely processing of adverse event reports.
Oversee receipt, entry, review, coding, and expedited reporting of adverse events and serious adverse events adhering to client and regulatory requirements.
Manage safety data quality, coordinate safety committees, participate in audits, prepare safety presentations, and supervise junior team members as needed.
Education ranging from Non-degree with 6-7 years safety experience up to PharmD with 1-3 years safety experience; degree fields preferred: Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry.
Work experience: Safety experience including processing AE/SAE reports, generating narratives, using safety databases, and regulatory submissions.
Knowledge of global pharmacovigilance regulations, Good Clinical Practice (GCP), ICH guidelines, medical/drug terminology, and aggregate reporting.
Travel availability of 10-15%; EudraVigilance Certification preferred but not mandatory.
Experienced in managing comprehensive drug safety operations with strong familiarity of pharmacovigilance compliance and safety databases.
Capable of coordinating multiple stakeholders including clients, regulatory bodies, clinical operations, and safety committees with leadership skills.
Skilled in quality control, audit preparation, staff mentoring, and managing financial and project deliverables within regulated environments.