Director – Senior Director, Pharmacovigilance Operations

Rezolute, Inc.

. Develop and execute the pharmacovigilance strategy supporting late-stage clinical development, regulatory approval, product launch, and post-marketing surveillance .

Posted 10/2/2026full-timeRemote • United StatesSenior💰 $255,000 - $315,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance strategy, including late-stage clinical development, regulatory compliance, and risk management. Proven ability to lead cross-functional teams and manage vendor relationships while ensuring adherence to global pharmacovigilance regulations.

Highest-signal resume keywords

Pharmacovigilance Strategy DevelopmentRegulatory ComplianceSignal Detection and ManagementAggregate Safety ReportingVendor Governance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceClinical DevelopmentRisk Management PlanningICSR ManagementSafety GovernanceBenefit-Risk AssessmentAdverse Event ReportingQuality SystemsCAPA ProcessesRegulatory Submissions

Soft Skills

LeadershipCollaborationCommunicationStrategic ThinkingProblem Solving

Tools & Technologies

Oracle Argus SafetySafety DatabasePV Technology Environments

Certifications & Qualifications

Advanced Degree in Health or Life Sciences

Industry Keywords

Pharmaceutical IndustryBiotechnologyRegulatory AuthoritiesFDAEMAICHPost-Marketing SurveillanceClinical-to-Commercial TransitionOutsourced PV OperationsSDEAs

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Develop and execute the pharmacovigilance strategy supporting late-stage clinical development, regulatory approval, product launch, and post-marketing surveillance
Establish a scalable PV operating model for the anticipated commercial footprint, product portfolio, geographic expansion, and partnership structure
Serve as a senior safety leader and subject matter expert across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Legal, and other functions
Provide safety input into clinical development plans, regulatory submissions, labeling strategies, launch-readiness activities, medical information processes, and lifecycle management
Represent Pharmacovigilance on cross-functional governance and product development teams
Lead PV readiness activities for transition from clinical-stage to commercial-stage pharmacovigilance
Develop and maintain a comprehensive PV launch-readiness plan
Establish processes for adverse event and product complaint intake, reconciliation, escalation, and reporting
Establish PV requirements and training for employees, contractors, vendors, field-based personnel, and other groups receiving adverse event information
Ensure PV systems, procedures, resources, vendors, and governance structures are operational and inspection-ready before product launch
Establish and oversee signal detection, validation, prioritization, assessment, management, and documentation
Lead cross-functional safety review or Safety Management Team meetings
Oversee aggregate safety reports and periodic benefit-risk assessments, including DSURs, PBRERs/PSURs, and other periodic reports
Lead or contribute to Risk Management Plans and risk minimization activities
Partner with Regulatory Affairs and Clinical Development on labeling changes, investigator communications, regulatory responses, and health authority interactions
Provide strategic and operational oversight of adverse event case management across clinical and post-marketing sources
Ensure collection, assessment, processing, follow-up, quality review, and submission of ICSRs within regulatory timelines
Oversee PV vendors, including safety database, case-processing, medical review, literature surveillance, and aggregate reporting providers
Establish operational metrics, quality indicators, and vendor performance measures
Develop internal versus outsourced capabilities based on company growth, volume, geographic footprint, and portfolio requirements
Ensure reconciliation of safety information across clinical databases, medical information, quality/product complaints, partners, patient support programs, and other systems
Partner with Quality Assurance to establish and maintain the pharmacovigilance quality system
Develop, implement, and maintain PV policies, SOPs, work instructions, and controlled processes
Establish deviation, CAPA, quality-event, and compliance-monitoring processes
Maintain continuous PV inspection readiness and participate in regulatory authority, partner, vendor, and internal audits
Ensure documentation demonstrates effective oversight of outsourced PV activities
Support PV system documentation and regulatory requirements, including the PSMF where required
Develop and maintain SDEAs and pharmacovigilance provisions in licensing, distribution, co-development, and commercialization agreements
Establish responsibilities for case exchange, aggregate reporting, signal management, regulatory submissions, reconciliation, and safety governance
Represent the company on joint safety committees and alliance governance forums
Monitor partner compliance with contractual PV obligations and implement corrective actions
Maintain current knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other relevant health authorities
Ensure PV processes remain compliant as products transition from investigational to marketed status and expand geographically
Support health authority meetings and responses to regulatory questions regarding product safety and benefit-risk

Requirements

What you’ll need

Advanced degree in a health or life sciences discipline strongly preferred, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training
Candidates with a master's or bachelor's degree and significant relevant pharmacovigilance leadership experience may also be considered
Director: Typically 10+ years of pharmaceutical/biotechnology industry experience, including approximately 7+ years in pharmacovigilance/drug safety
Senior Director: Typically 12–15+ years of pharmaceutical/biotechnology industry experience with substantial progressive leadership responsibility within pharmacovigilance
Demonstrated experience supporting late-stage clinical development and/or marketed products
Experience managing outsourced PV operations and vendors
Senior Director: demonstrated leadership of PV activities through late-stage development, regulatory approval, and commercial launch
Senior Director: experience establishing or significantly scaling a pharmacovigilance function
Experience interacting with senior executives, health authorities, strategic partners, and regulatory inspectors
Strong working knowledge of global pharmacovigilance regulations and regulatory reporting requirements
Strong working knowledge of ICSR management and expedited reporting
Strong working knowledge of signal detection and signal management
Strong working knowledge of aggregate safety reporting
Strong working knowledge of benefit-risk assessment
Strong working knowledge of risk management planning and risk minimization
Strong working knowledge of safety governance
Strong working knowledge of safety database and PV technology environments
Strong working knowledge of SDEAs and partner pharmacovigilance oversight
Strong working knowledge of vendor governance and outsourced PV models
Strong working knowledge of PV quality systems, CAPAs, audits, and inspection readiness
Strong working knowledge of clinical-to-commercial PV transition
Experience with commercial safety systems such as Oracle Argus Safety or equivalent validated safety database platforms is desirable

Benefits

Comp & perks

Annual performance bonus
Health Insurance (Medical / Dental / Vision)
Disability, Life & Long-Term Care Insurance
Holiday Pay
Tracking Free Vacation Program
401(k) Plan Match
Educational Assistance Benefit
Fitness Center Reimbursement