Philisha Mack
Vice President, Global Drug Safety @Azurity Pharmaceuticals
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WORK HISTORY
Vice President, Global Drug Safety @Azurity Pharmaceuticals
US
Provide executive leadership for global drug safety strategy across the full product lifecycle, ensuring patient safety, regulatory compliance, and scientific rigor at scale • Lead and evolve a globally aligned, risk-based, and data-driven pharmacovigilance organization supporting development and post-marketing portfolios • Partner cross-functionally with Medical Affairs, Regulatory, Clinical Development, Quality, and Commercial teams to embed proactive safety oversight into enterprise decision-making • Drive global consistency while accounting for regional regulatory requirements and operational needs • Build, mentor, and empower high-performing global teams with a focus on accountability, collaboration, and talent development • Oversee signal detection, risk management, benefit-risk assessments, and safety governance to support informed and timely decision-making • Champion continuous improvement, operational excellence, and modernization of drug safety processes, systems, and capabilities • Serve as a senior safety leader engaging with health authorities and internal stakeholders to uphold trust, transparency, and patient-first outcomes
EDUCATION
Hampton University
Doctor of Philosophy (PhD), Family Research
DIA
PV Quality Mgmt., Benefit-Risk Assessment and Mgmt. Across the Lifecycle,The PV Quality Mgmt System, PV Quality Mgmt., Benefit-Risk Assessment and Mgmt. Across the Lifecycle,The PV Quality Mgmt System
Communispond
Executive Presentation Certification, Executive Presenter
Aveda Business Institute
Six Sigma Black Belt Certification, Six Sigma Black Belt Certification
Emory University - Goizueta Business School
Executive MBA, Mba
The Capp Institute
Certified Life-Coach -Psychology Principle, Executive Coach
SKILLS
ABOUT PHILISHA MACK
FNP and Certified Six Sigma Black Belt with global management experience in Pharma, Medical Device, Litigation, Regulatory Affairs, product/patient safety, post-market, regenerative medicine, cellular therapy, safety surveillance, and aggregate data.Currently completing PhD with a focus on Cancer Related Fatigue in Breast Cancer Survivors.Passionate Pharmacovigilance professional with strong record of success in management of safety. Strong knowledge of global pharmacovigilance regulations and track record of successful implementation of PV requirements. Lead cross functional teams to harmonize safety systems and processes. Exceptional interpersonal skills with a proven ability to manage diverse teams across the spectrum. Therapeutic Areas:•Cardiovascular•Immunology•Hospice Care•Family Practice•EndocrinologyAreas of Expertise:•Safety & Surveillance•Global Safety Management•Pharmacovigilance•Medical Writing (IB, SMP,Contracts,RMP, DSUR,Annual Reports)•Medical Communication (KOLs, Safety & Marketing Approval, Safety Management Profiles) •Leadership & Ethics•MDR Submission (Litigation Cases) InformData Bases:•Clintrace•Argus•MeDdra•WhoDrug•Trackwise•AERsProfessional Networks:ANCCPittsburgh Young ProfessionalsDIAASQSupport the oversight of pharmacovigilance service vendors • Assist in production and review of safety sections of GCP documents (e.g. investigators’ brochure, informed consent forms) • Assist in safety review, aggregate reporting and data reconciliation • Search and retrieve safety data from safety and clinical trial databases
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