Senior Director, Global Pharmacovigilance & Safety

Jobtailor; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

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

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.