Manager, Global Drug Safety – Pharmacovigilance

Asahi Kasei

Management oversight, planning, and execution of drug safety activities at Veloxis Pharmaceuticals. Ensuring compliance and quality in collaboration with cross-functional teams and partners.

Posted 7/17/2026full-timeCary • North Carolina • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and drug safety management, including vendor oversight, compliance with global regulations, and effective communication with cross-functional teams. Proficient in ICSR processing, safety management plan development, and maintaining inspection readiness.

Highest-signal resume keywords

Pharmacovigilance ExperienceVendor ManagementICSR ProcessingArgus Database ProficiencyRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceDrug Safety ManagementAdverse Event ProcessingSafety Management Plan DevelopmentData MigrationKPI EstablishmentRegulatory ReportingQuality AuditsAggregate Report ReviewOperational Excellence

Soft Skills

Detail-OrientedSelf-MotivatedProblem SolvingEffective CommunicationTeam Collaboration

Tools & Technologies

ArgusMS OfficeAdobe Pro

Industry Keywords

Clinical Trial SafetyDrug SafetyPharmacovigilance RegulationsInspection ReadinessLife Sciences Degree

About the role

Key responsibilities & impact

Provide management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence
Serve as a safety liaison with the Company’s cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance
Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to: Oversight of US AE call center; Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs; Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter; Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners; Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP); Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF); Provision of vendor project specific training; Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates; Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; and Maintaining knowledge of safety systems (Argus experience preferred);
Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines
Support internal / external audits and regulatory inspections
Assist in management of pharmacovigilance vendor contracts and forecasting activities
Assist in management of license partner safety data exchange agreements (SDEA)
Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company’s policies and procedures
Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports
Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization
Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance
Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession with relevant experience
At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products
Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, establishment of KPIs / metrics, and contract management
Strong knowledge of ICSR processing and the adverse event lifecycle
Solid experience with drug safety databases, especially with Argus; data migration experience preferred
Ability to independently identify, analyze, and solve complex operational and data‑related issues
Strong understanding of current pharmacovigilance practices and global pharmacovigilance regulations, including regulatory reporting requirements
Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
Excellent written and verbal communication skills
Ability to work both independently and within a matrixed team in a dynamic, fast-paced environment with shifting priorities
Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro

Benefits

Comp & perks

health and insurance benefits
training and development opportunities
performance-based bonus eligibility