Senior Medical Director, Pharmacovigilance

MapLight Therapeutics, Inc.

Senior Medical Director leading pharmacovigilance and safety evaluation at MapLight Therapeutics. Overseeing safety management teams and benefit-risk assessments throughout product lifecycles.

Posted 7/13/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $319,000 - $361,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading product safety surveillance and managing benefit-risk profiles throughout the product life cycle, with a strong focus on safety data analysis and regulatory compliance. Proven ability to develop and implement drug safety strategies and risk management plans while effectively collaborating with cross-functional teams.

Highest-signal resume keywords

MD Or EquivalentDrug Safety/Pharmacovigilance ExperienceSafety Data AnalysisSignal ManagementRisk Management Plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Data AnalysisSignal DetectionBenefit-Risk EvaluationMedical Review of Adverse EventsAuthoring Clinical Study DocumentsRegulatory Submission DocumentsDevelopment of Risk Management PlansSafety Database Knowledge

Soft Skills

Effective Oral CommunicationEffective Written CommunicationLeadershipCollaborationMentoring

Tools & Technologies

ArgusArisGLifeSphere Safety

Industry Keywords

PharmacovigilanceClinical ExperienceRegulatory RequirementsCross-Functional Team LeadershipSafety Management Team

About the role

Key responsibilities & impact

Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products.
Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle.
Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products.
Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content.
Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses.
Provide strategy and guidance to safety risk management scientists in writing of periodic reports for assigned products; provide medical interpretation, review and approval.
Responsible for up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
Perform the medical review of all adverse event reports for seriousness, expectedness and causality.
Coach, mentor and manage safety scientists supporting the surveillance activities for assigned products.

Requirements

What you’ll need

MD or equivalent with 3-5 years of relevant clinical experience
Minimum 10 years’ industry experience, within Drug safety/Pharmacovigilance with investigational and/or marketed products
Proven experience in safety data analysis, signal management, and benefit-risk evaluation
Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
Demonstrated ability to develop and implement drug safety strategies and risk management plans
Proven experience with authoring or contributing to clinical study and regulatory submission documents
Working knowledge of relevant local and global regulatory requirements and guidance documents
Able to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
Effective oral and written communication skills.
Highly motivated, self-driven and dependable.

Benefits

Comp & perks

annual bonus opportunity
medical
dental
vision
life and AD&D
short term and long term disability
401(K) plan with match
stock options
flexible non-accrual paid time off
parental leave