Senior Director, Pharmacovigilance

Jobtailor

San Francisco (CA)

On-site

USD 180,000 - 240,000

Full time

14 days+

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Job summary

Jobtailor seeks a senior Pharmacovigilance leader to oversee PV operations and compliance across the product lifecycle, building robust infrastructure for global Phase 3 programs and commercialization.

Responsibilities include ICSR handling, safety surveillance, DSURs/PSURs, and regulatory submissions, with vendor oversight and inspection readiness. Requirements include a Health Care degree and 10+ years in drug safety.

Qualifications

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 R&D processes.
Experience authoring and/or overseeing aggregate safety reports (DSURs, PBRERs/PSURs, IND Annual Reports, Investigator Brochures).
Experience with safety surveillance, signal detection, risk management, and health authority interactions.
Experience writing safety sections of marketing applications and defending contents to Health Authorities.
Experience supporting regulatory submissions (INDs, CTAs, NDA/BLA/MAA).
Experience developing SDEAs, PVAs, Safety Management Plans; and oversight of external partners.

Responsibilities

Lead PV activities for development and commercialization portfolios.
Oversee PV operations and compliance across the product lifecycle.
Build PV infrastructure, systems, and oversight frameworks for global programs.
Oversee ICSR collection, review, processing, and reporting.
Lead safety surveillance, signal detection, evaluation, and risk management.
Lead aggregate safety reporting (DSURs, PSURs, RSI).
Support RMPs, REMS, and Safety Management Plans.

Skills

Pharmacovigilance

Drug Safety

Safety Surveillance

Regulatory Submissions

Aggregate Safety Reporting

Education

MD/DO/PhD/NP/PharmD (Health Care degree)

Tools

CRO Management

PV Vendor Oversight

Inspection Readiness Tools

CAPA Management Systems

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.

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