Director, Pharmacovigilance Operations

MapLight Therapeutics, Inc.

. Develop strategy for PV operations and support PV Head in implementing strategy and vision for the PV function .

Posted 10/16/2026full-timeRemote • United StatesLead💰 $205,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance operations, including case management, vendor oversight, and regulatory compliance. Proven ability to lead strategic initiatives, manage cross-functional collaborations, and ensure quality in safety data processing and reporting.

Highest-signal resume keywords

Pharmacovigilance ExperienceGlobal PV RegulationsVendor ManagementSafety Data ReviewsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case ManagementAggregate ReportingSignal DetectionRisk Management PlansMedDRA CodingICSR Case ProcessingSOP DevelopmentQuality ComplianceData Flow ManagementSafety Systems

Soft Skills

Strategic ThinkingExceptional CommunicationCross-Functional CollaborationMentoringSelf-Driven

Tools & Technologies

MPLT Safety SystemSafety Database

Certifications & Qualifications

Health Care Professional DegreeAdvanced Degree in Biomedical Sciences

Industry Keywords

Pharmaceutical IndustryBiopharmaceuticalGVP GuidelinesICH GuidelinesClinical OperationsSafety SurveillanceTMF ContributionsAudits and Inspections

About the role

Key responsibilities & impact

Develop strategy for PV operations and support PV Head in implementing strategy and vision for the PV function
Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting
Manage implementation of the MPLT safety system, including safety database and processes, for regulatory-compliant ICSR case processing
Oversee PV vendor and contract management, including third-party CROs and partners
Oversee safety-related alliance management, including SDEAs
Manage information and data flow between clinical and PV vendors in collaboration with Clinical Operations
Oversee quality and compliance for ICSR case processing and reporting KPIs
Develop, contribute to, review, and maintain current ICSR case-processing SOPs, forms, and SMPs
Liaise with safety surveillance and cross-functional teams to support timely dissemination of safety deliverables
Collaborate with Quality and lead PV contributions for audits and inspections
Manage PV functional deliverables and projects
Oversee PV functional contributions to TMFs
Manage PV budget and vendor resources
Coach and mentor PV Operations associates
Report to the Vice President, Pharmacovigilance

Requirements

What you’ll need

Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science
Minimum 8 years of pharmacovigilance experience within the biopharmaceutical industry, with at least 3 years in leading PV operations
Competence in conducting safety data reviews, vendor management, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post marketed products
Experience with MedDRA and drug coding reviews
Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
Demonstrated PV project management skills in a fast-paced organization
Exceptional communication and cross-functional collaboration skills
Strategic thinking and ability to translate complex safety data into actionable insights for regulatory and clinical decision-making
Ability to work within a growing organization and help the organization evolve over time
Ability to engage in open, constructive and continuous dialogue with company stakeholders based on equality and mutual respect
Highly motivated, self-driven and dependable
Committed to MapLight's Core Beliefs and Values
Ability to travel as needed, up to 10%, for corporate and departmental meetings

Benefits

Comp & perks

Annual bonus opportunity
Medical insurance
Dental insurance
Vision insurance
Life insurance
AD&D insurance
Short-term disability
Long-term disability
401(K) plan with match
Stock options
Flexible non-accrual paid time off
Parental leave
Ability to travel as needed (up to 10%) for corporate and departmental meetings