Senior Medical Director, DSPV

Celcuity

Senior Medical Director specializing in drug safety and pharmacovigilance at Celcuity. Responsible for medical oversight of safety vendor activities and collaboration with cross-functional teams.

Posted 7/23/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $338,000 - $366,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in drug safety and pharmacovigilance, with a strong focus on safety signal management, benefit-risk assessment, and regulatory compliance. Proficient in utilizing commercial safety databases and preparing comprehensive safety reports.

Highest-signal resume keywords

Drug Safety/Pharmacovigilance ExperienceMedical DegreeGlobal Drug Safety Regulations KnowledgeCommercial Safety Databases (Argus or ARIS-G)Project Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Signal ManagementBenefit Risk AssessmentPreparation of Aggregate ReportsMedDRA Coding PracticesWHO Drug Coding Practices

Soft Skills

Excellent Verbal CommunicationPresentation SkillsMultitasking AbilityPrioritization Under Tight Timelines

Tools & Technologies

Electronic Data Capture Systems

Industry Keywords

Safety OperationsAdverse Event ReportsSOP DevelopmentSafety Data Exchange AgreementsData Safety Monitoring Board (DSMB)

About the role

Key responsibilities & impact

Responsible for medical oversight of safety vendor(s)
Provide day-to-day medical support for the Safety Operations team
Reviews incoming adverse event reports
Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents
Support safety inspection readiness activities
Support the requirements of Safety Data Exchange Agreements with Celcuity partners
Reviews and provides input on the safety sections of clinical documents
Support the development of internal and external key performance indicators and metrics
Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
Perform safety signal management and benefit risk assessment activities

Requirements

What you’ll need

10+ years of drug safety/pharmacovigilance experience
Medical degree
Training in medical or radiation oncology, hematology or related field preferred
Comprehensive knowledge of global drug safety related regulations and work practices
Extensive experience with commercial safety databases (Argus or ARIS-G) and electronic data capture systems
Experience with the preparation of aggregate reports (i.e., DSUR, PSUR/PBRER, PADER, RMP, ISS) and ICF and IB updates
Excellent knowledge of MedDRA and WHO Drug coding practices
Excellent verbal communication and presentation skills
Strong project management skills
Ability to multitask and prioritize under tight timelines

Benefits

Comp & perks

medical, dental, vision insurance
401(k) match
PTO
paid holidays
annual performance incentive bonus
new hire equity package