Senior Manager, Drug Safety – Pharmacovigilance

Travere Therapeutics

. Support pre- and post-marketing pharmacovigilance activities across DSPV Operations and Safety Science .

Posted 10/15/2026full-timeSan Diego • California • United StatesSenior💰 $132,000 - $172,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in pharmacovigilance operations, including ICSR processing, safety data reconciliation, and compliance with global regulatory requirements. Proficient in developing safety management plans and conducting quality reviews of safety documentation.

Highest-signal resume keywords

Pharmacovigilance Operations ManagementICSR Processing and Medical ReviewSafety Data ReconciliationRegulatory Compliance KnowledgeAggregate Safety Report Contribution

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

PharmacovigilanceICSR ProcessingSafety Data ReconciliationSignal DetectionMedDRA CodingRegulatory Reporting ComplianceQuality ReviewSafety SurveillanceVendor OversightAggregate Safety Reports

Soft Skills

Analytical SkillsCritical ThinkingWritten CommunicationVerbal CommunicationOrganizational Skills

Tools & Technologies

ARGUSARISgMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

Certifications & Qualifications

Bachelor's Degree in Life SciencesHealthcare Professional Qualification (RN, BSN, PharmD, PA, NP)

Industry Keywords

Drug SafetyPharmacovigilanceClinical DevelopmentPost-MarketingFDA RegulationsICH GuidelinesGCP RequirementsREMS ProgramsNephrologyRare Diseases

About the role

Key responsibilities & impact

Support pre- and post-marketing pharmacovigilance activities across DSPV Operations and Safety Science
Manage day-to-day pharmacovigilance operations performed internally and by PV service providers
Monitor compliance with global regulatory requirements and expedited safety-reporting timelines
Perform quality review of ICSRs, safety forms, narratives, and other safety documentation
Monitor PV vendor performance, KPIs, compliance metrics, quality findings, and operational issues
Perform safety data reconciliations, including SAE reconciliation with clinical databases and vendor reconciliations
Support PV activities involving business and licensing partners and pharmacovigilance agreements
Develop and maintain Safety Management Plans, Vendor Oversight Plans, and SAE Reconciliation Plans
Lead or coordinate PV deviation and quality-event investigations and CAPA activities
Support inspection and audit readiness and participate in regulatory inspections and audits
Contribute to PV SOPs, work instructions, procedural documents, and training materials
Support departmental project management, safety team meetings, deliverable tracking, documentation, and archiving
Perform medical review of ICSRs from clinical trials and post-marketing sources
Review clinical safety data, MedDRA coding, and other safety-related coding
Contribute to aggregate and periodic safety reports, including DSURs, PADERs, PSURs/PBRERs, line listings, and ad hoc analyses
Review safety sections of clinical and regulatory documents
Support safety signal detection, evaluation, validation, assessment, documentation, and tracking
Assist with Risk Management Plans and risk-management documentation
Prepare and review responses to health authority safety inquiries
Support REMS activities, vendor oversight, materials review, and compliance monitoring
Act as a DSPV subject matter expert in cross-functional safety governance and review meetings
Perform additional duties as assigned

Requirements

What you’ll need

Bachelor's degree in life sciences or related field required
6+ years of experience in Drug Safety/Pharmacovigilance within the pharmaceutical, biotechnology, or CRO industry
Experience in both clinical development and post-marketing pharmacovigilance environments
Strong experience with ICSR processing and/or medical review, including seriousness, expectedness, causality, coding, case narratives, query management, and regulatory reporting compliance
Experience with reconciliation activities, case quality review, and vendor oversight
Experience with safety surveillance and signal detection activities
Experience contributing to aggregate safety reports such as DSURs, PADERs, PSURs/PBRERs, and other periodic or ad hoc safety analyses
Experience reviewing safety information in clinical study documents
Experience with pharmacovigilance/safety database systems such as ARGUS, ARISg, or equivalent
Experience in MedDRA and WHO Drug coding conventions
Working knowledge of FDA regulations, ICH guidelines, GCP requirements, EU pharmacovigilance requirements, and other applicable global requirements
Strong analytical and critical-thinking skills
Strong written and verbal communication skills
Ability to work independently and collaborate in cross-functional and matrixed team environments
Strong organizational, prioritization, and time-management skills
Proficient in Microsoft Word, Excel, and PowerPoint
Ability to travel 10% domestically and internationally, including occasional nights and weekend travel
Healthcare professional or relevant health/biomedical science degree; RN, BSN, PharmD, PA, NP, or similar healthcare-related qualification preferred
Knowledge of REMS programs and/or REMS program management preferred
Experience in nephrology and/or rare diseases preferred

Benefits

Comp & perks

Premium health, financial, work-life and well-being offerings for eligible employees and dependents
Wellness and employee support programs
Life insurance
Disability insurance
Retirement plans with employer match
Generous paid time off
Short-term incentive
Long-term incentive compensation (company stock)