Pharmacovigilance Operations Manager

Revance

Manager, Pharmacovigilance Operations leading patient safety operations at Revance. Overseeing compliance and safety surveillance for pharmaceuticals and medical devices.

Posted 7/27/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance, including end-to-end case processing, signal detection, and compliance with global GVP regulations and ICH guidelines. Proficient in managing safety databases and leading cross-functional collaborations to ensure timely and accurate safety reporting.

Highest-signal resume keywords

Pharmacovigilance ExperienceEnd-to-End Case ProcessingSignal DetectionSafety Database ManagementGlobal GVP Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceCase ProcessingSignal DetectionSafety SurveillanceSafety Data AnalysisRegulatory ComplianceClinical Trial LifecycleSafety Database (Argus)ICSR/MDR Lifecycle ManagementAttention to Detail

Soft Skills

Cross-Functional CollaborationRelationship ManagementOrganizational SkillsWritten CommunicationVerbal Communication

Tools & Technologies

Safety Reporting PortalPharmacovigilance System Master File (PSMF)

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceICH GuidelinesGVP RegulationsClinical DevelopmentVendor OversightAudit ReadinessSOPsQuality Metrics

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Leads global Patient Safety Operations and effectively manages select safety surveillance projects for multiple product categories, including prescription drugs, class I, II, and III medical devices, OTC drugs, and cosmetics.
Manages communications with vendors, CROs, QPPVs, and partners regarding the evaluation, processing, and reconciliation of case reports (ICSRs, MDRs, cosmetic AE reports).
Manages communications with the clinical development team regarding safety data exchange and reconciliation between clinical and safety databases for clinical studies.
Ensures that all safety reports received by the Patient Safety group from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
Reviews all cases to ensure the accuracy, integrity and completeness of information entered in the safety database.
Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as required and on time.
Maintains the company electronic safety reporting portal, collates suggested inputs from cross-functional groups, and communicates with IT to ensure appropriate implementation.
Leads PV compliance monitoring.
Maintains the company core Pharmacovigilance System Master File (PSMF). Collates inputs from relevant cross-functional partners and updates the PSMF quarterly. Coordinates regional PSMF updates with QPPVs.
Maintains and updates PV SOPs, vendor Joint Operating Guidelines (JOGs) and relevant departmental policies.
Ensures continuous inspection and audit readiness of the Revance pharmacovigilance system by maintaining compliant processes, complete and inspection-ready documentation, effective vendor oversight, and measurable quality and compliance metrics.
Monitors and identifies possible trends and concerns related to the use of Revance products, and key competitor products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
Leads signal detection and analysis, as well as preparation and submission of signal reports.

Requirements

What you’ll need

Master's degree in Life Sciences, Pharmacology, Public Health, Nursing, or a related scientific field with 6–8+ years of pharmacovigilance experience, OR Bachelor's degree with 8+ years of relevant experience
Progressive experience within pharmaceutical, biotechnology, or medical device environments
Direct experience with:
End-to-end case processing and ICSR/MDR lifecycle management
Safety databases (Argus preferred)
Signal detection and safety surveillance activities
Strong understanding of:
Global GVP regulations and ICH guidelines
Pharmacovigilance compliance requirements
Regulated processes and clinical trial lifecycle
Experience analyzing and interpreting safety data and assessing clinical relevance
Demonstrated ability to manage multiple priorities and lead projects independently
Strong cross-functional collaboration and relationship management skills
Excellent written and verbal communication skills
High attention to detail and strong organizational skills

Benefits

Comp & perks

Competitive Compensation including base salary and annual performance bonus.
Flexible PTO, holidays, and parental leave.
Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!