Director, Global Drug Safety – Pharmacovigilance Operations

Asahi Kasei

. Lead and provide direction for all product safety and pharmacovigilance activities in compliance with global requirements .

Posted 10/27/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance and product safety, including regulatory compliance, risk management, and safety data management. Proven ability to lead teams, develop strategies, and maintain quality systems in alignment with global pharmacovigilance standards.

Highest-signal resume keywords

Pharmacovigilance LeadershipDrug Safety ExperienceUS And EU Regulatory KnowledgeVendor ManagementProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceRisk ManagementSafety Data ManagementSignal DetectionAggregate Safety ReportsCore Safety InformationDrug Safety DatabasesRegulatory SubmissionsTraining ComplianceAudit Experience

Soft Skills

Leadership QualitiesDetail-OrientedOrganizational SkillsCommunication SkillsSelf-Motivated

Tools & Technologies

ArgusMS OfficeAdobe Pro

Industry Keywords

Pharmacovigilance System Master FileGlobal RegulationsClinical DevelopmentPostmarketing ProgramsSafety Management Team

About the role

Key responsibilities & impact

Lead and provide direction for all product safety and pharmacovigilance activities in compliance with global requirements
Develop GDSPV operations strategy, goals, objectives, implementation, and training
Manage pre- and post-marketing safety surveillance activities throughout product lifecycles
Provide pharmacovigilance leadership for clinical development and postmarketing programs while collaborating with internal and external stakeholders
Prepare and review safety sections of clinical, regulatory, and scientific documents and submissions
Direct creation and maintenance of Core Safety Information and Reference Safety Information
Oversee aggregate safety reports, including PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, and SUSAR line listings
Oversee risk-benefit evaluations and Risk Management Plans
Develop and manage pharmacovigilance activities and safety data exchange agreements with license partners
Govern vendors, including adverse event/product complaint call centers, outsourced ICSR processing, monitoring reports, and safety database operations
Develop and maintain the pharmacovigilance quality system and Pharmacovigilance System Master File
Create and maintain SOPs and working practices for inspection readiness and regulatory compliance
Serve as pharmacovigilance subject matter expert during audits and regulatory inspections
Manage pharmacovigilance budget and forecasting
Support signal detection, safety assessments, and Safety Management Team and Benefit Risk Assessment Team meetings
Represent the company in product safety meetings with license partners and CROs
Provide pharmacovigilance training and manage training compliance
Maintain current knowledge of global regulations and guidelines

Requirements

What you’ll need

Bachelor’s degree in scientific / technical discipline, RN, or equivalent healthcare experience
At least 7 years’ drug safety experience in the pharmaceutical industry
Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices
Solid experience with drug safety databases, especially with Argus
Solid vendor management/governance experience
Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
Excellent leadership qualities and written and verbal communication skills
Ability to work in a dynamic, fast-paced environment with shifting priorities
Experience with internal audits and global regulatory inspections
Strong organizational and project management skills
Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Travel Requirements: <10%

Benefits

Comp & perks

Equal opportunity employer committed to a diverse workforce
Remote work arrangement
Travel requirements: <10%