Senior Safety Physician – CNS

Eli Lilly and Company

. Provide medical safety oversight for Phase 2/3 and other late-stage clinical studies .

Posted 10/10/2026full-timeRemote • United StatesSenior💰 $222,000 - $356,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Drug Safety and Pharmacovigilance, with a strong focus on late-stage clinical development, safety signal evaluation, and regulatory submissions. Proven ability to collaborate cross-functionally and communicate safety findings effectively to senior leadership.

Highest-signal resume keywords

MD Or DO Medical Degree5+ Years Pharmaceutical Biotech ExperienceExpertise In Safety Signal EvaluationKnowledge Of FDA EMEA ICH RegulationsExperience With NDA Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug SafetyPharmacovigilanceSafety Signal EvaluationAggregate Safety AssessmentBenefit-Risk EvaluationRegulatory SubmissionsClinical Protocol DevelopmentSafety Monitoring PlansRisk Management PlansIntegrated Safety Analyses

Soft Skills

Strong Clinical JudgmentScientific CommunicationInterpersonal SkillsCross-Functional CollaborationAdaptive Problem-Solving

Industry Keywords

Late-Stage Clinical DevelopmentPost-Marketing ActivitiesGlobal PharmacovigilanceRisk Management RegulationsCNS Program Development

About the role

Key responsibilities & impact

Provide medical safety oversight for Phase 2/3 and other late-stage clinical studies
Review and interpret individual and aggregate safety data, including identification and evaluation of safety signals
Lead or contribute to safety surveillance, signal management, literature surveillance and benefit-risk assessments
Provide medical input into DSURs, PBRERs/PSURs, Risk Management Plans, Investigator's Brochures, and NDA submissions
Support regulatory interactions and responses to FDA and other health authorities globally
Partner with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs
Provide safety input into clinical protocols, safety monitoring plans, and development strategies
Support preparation for regulatory submissions, inspections, and audits
Communicate safety findings and recommendations to cross-functional teams and senior leadership
Help build the medical safety function at Centessa through gap analysis, SOP authorship and review, best-practice implementation, and partnership with Eli Lilly's broader Global Safety function
Report to the Associate Vice President of Pharmacovigilance and Safety

Requirements

What you’ll need

MD, DO, or equivalent medical degree
5+ years of pharmaceutical/biotech industry experience in Drug Safety/Pharmacovigilance or a closely related discipline
Demonstrated experience with late-stage clinical development and NDA submissions as well as post-marketing activities
Ability to drive drug safety evidence generation and risk mitigation strategies in a complex internal and external environment
Expertise in safety signal evaluation, aggregate safety assessment, and benefit-risk evaluation
Sound knowledge and experience with FDA, EMEA/EU, ICH and other global pharmacovigilance and risk management regulations and guidelines
Strong clinical judgment, scientific communication, interpersonal and cross-functional collaboration skills
Ability to thrive in a fast-paced, entrepreneurial biotech environment
Experience supporting a CNS program through late-stage development and NDA submission/approval, as well as experience with regulatory interactions and integrated safety analyses (Additional Preference)
Curiosity and passion for the work
Ability to embrace ambiguity and push for new practices and technologies
Adaptive problem-solving ability
Technical depth and growth mindset
Curiosity and drive for innovation, especially in artificial intelligence and digital (Additional Preference)

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Employee resource groups open to all employees