Senior Director, Pharmacovigilance

Job description

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

Pharmacovigilance

Drug Safety

Safety Surveillance

Regulatory Submissions

Aggregate Safety Reporting

Hard Skills

Pharmacovigilance Regulations

Signal Detection

Risk Management

Safety Data Reconciliation

Aggregate Safety Reports

IND Submissions

CTAs

NDA/BLA/MAA Submissions

Safety Management Plans

Clinical Development

Soft Skills

Interpersonal Skills

Written Communication

Verbal Communication

Proactive Attitude

Adaptability

Certifications & Qualifications

Degree in Health Care

Industry Keywords

Pharmaceutical

Biotechnology

Clinical Development

Post-Marketing

Health Authority Interactions

Tools & Technologies

CRO Management

PV Vendor Oversight

Inspection Readiness Tools

CAPA Management Systems

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Worksite address

san francisco, CA, 94199, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.