Serve as a product lead for Pharmacovigilance activities
Oversee and lead safety signal management processes and aggregate reports
Respond to safety inquiries from internal and external stakeholders
Review medical and scientific literature for safety information
Support Clinical Trial PV medical activities
Collaborate with leadership to hire, train, mentor, and manage staff focused on specific products
Guide Safety and cross-functional teams on global safety regulations, data analyses, and product-specific information
Conduct ongoing safety data reviews and signal detection activities
Lead signal management activities, including detection, tracking, documentation, evaluation, authoring signal evaluation reports, and leading Safety Signaling Team meetings
Manage literature review activities
Oversee strategy, review, and finalization of PSURs, DSURs, RMPs, and related safety documents
Prepare scientifically robust responses to regulatory authorities
Collaborate with Global Safety Officers and Safety MDs on investigational programmes, clinical trial activities, and safety committee management
Manage ad hoc safety data analyses and information requests
Significant years of pharmacovigilance experience, including aggregate safety reports and safety signal management
Proficiency in interpreting, analyzing, and presenting scientific and medical data
Strong foundation in pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations
Basic knowledge of Excel, PowerPoint, Microsoft Word, Business Objects, and safety database systems
Demonstrated leadership and collaborative skills within team environments
Expertise in global safety regulations and guidelines preferred
Experience in mentoring and managing staff within pharmacovigilance settings preferred
Ability to apply clinical judgment in safety data interpretation preferred
Core Competencies
Demonstrates expertise in Pharmacovigilance activities, including safety signal management, regulatory compliance, and data analysis. Proven ability to lead teams, mentor staff, and collaborate effectively with cross-functional stakeholders in the pharmaceutical industry.
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