Senior Director, Pharmacovigilance
jobtailorMillbrae (CA)
About the role
Lead strategic and operational pharmacovigilance activities for development and future commercial portfolios Oversee PV operations and compliance throughout the product lifecycle Build and improve PV infrastructure, systems, processes, and oversight frameworks for global Phase 3 programs and commercialization Oversee ICSR collection, case review, processing, reconciliation, reporting, and quality activities Lead safety surveillance, signal detection, evaluation, management, and communication of emerging safety risks Lead aggregate safety reporting, including DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures, and other safety deliverables Support RMPs, REMS, Safety Management Plans, and other risk management activities Serve as PV subject matter expert for regulatory submissions and health authority interactions Provide case review, analysis, and guidance for SAE assessment, reporting, and safety issue escalation Contribute to safety sections of clinical and regulatory documents and marketing application submissions Lead operational PV activities for global co-development and licensing partnerships, including SDEAs, PVAs, safety governance, and partner data reconciliation Select, manage, and oversee PV vendors, CROs, and external service providers Support inspection readiness, audits, CAPA management, and continuous process improvement
Requirements:
- Degree in Health Care is required (e.g., MD, DO, PhD, NP, Pharm D)
- At least 10 years of experience in drug development at global pharmaceutical or biotechnology companies
- At least 7 years of experience in pharmacovigilance and drug safety across clinical development and post-marketing environments
- Strong knowledge of global pharmacovigilance regulations and Research & Development processes
- Experience authoring and/or overseeing aggregate safety reports, including DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures, and Reference Safety Information (RSI)
- Experience with safety surveillance, signal detection, signal evaluation, benefit-risk assessment, and risk management activities
- Experience writing safety sections of marketing applications and defending contents to Health Authorities
- Experience supporting global regulatory submissions, including INDs, CTAs, NDA/BLA/MAA submissions, and responses to Health Authority safety queries
- Experience developing and maintaining SDEAs, PVAs, and Safety Management Plans
- Experience with co-development, licensing, or alliance partners, including safety data reconciliation and partner oversight
- Experience selecting, managing, and overseeing CROs, PV vendors, and outsourced service providers
- Experience supporting pharmacovigilance inspections, audits, CAPA management, and inspection readiness activities
- Strong interpersonal, written, and verbal communication skills
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
- Flexible, proactive, hands-on, can-do attitude
Employment authorization verified through the federal E-Verify program
Core Competencies:
Demonstrates extensive expertise in pharmacovigilance and drug safety, including safety surveillance, signal detection, and regulatory submissions. Proven ability to lead operational activities, manage vendor relationships, and ensure compliance throughout the product lifecycle. Highest-signal resume keywords PharmacovigilanceDrug SafetySafety Surveillance Regulatory Submissions Aggregate Safety Reporting Hard Skills Pharmacovigilance Regulations Signal Detection Risk Management Safety Data Reconciliation Aggregate Safety ReportsIND SubmissionsCTAsNDA/BLA/MAA Submissions Safety Management Plans Clinical Development Soft Skills Interpersonal Skills Written Communication Verbal Communication Proactive Attitude AdaptabilityCertifications & Qualifications Degree in Health Care Industry Keywords PharmaceuticalBiotechnologyClinical Development Post-Marketing Health Authority Interactions Tools & TechnologiesCRO ManagementPV Vendor Oversight Inspection Readiness ToolsCAPA Management Systems
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this