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Director, Drug Safety
Spyre Therapeutics. Perform triage and medical review of Individual Case Safety Reports (ICSRs) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance, safety surveillance, and medical review, with a strong focus on regulatory compliance and risk management strategies. Proficient in leading cross-functional teams and developing safety documentation to support clinical development.
Highest-signal resume keywords
MD DegreeClinical Development Drug Safety ExperienceEpidemiology KnowledgeArgus Global Safety Database ProficiencySafety Surveillance and Signal Detection Experience
ATS Keywords
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Hard Skills
Medical ReviewAggregate Safety Document PreparationSignal ManagementBenefit-Risk ManagementSafety Risk Language DevelopmentData Monitoring Committee PresentationsPharmacovigilance ComplianceProcess ImprovementEpidemiology ProjectsSafety Data Review
Soft Skills
Analytical SkillsProblem-Solving SkillsCommunication SkillsInterpersonal SkillsTeam Motivation
Industry Keywords
Pharmaceutical IndustryBiotech IndustryGlobal Regulatory RequirementsEMA RegulationsFDA RegulationsPharmacoepidemiologySafety Management PlansSafety Surveillance PlansClinical Development PlansIntegrated Safety Reviews
About the role
Key responsibilities & impact- Perform triage and medical review of Individual Case Safety Reports (ICSRs)
- Oversee cases and Analysis of Similar Events (AOSEs) for expedited safety reporting
- Lead cross-functional medical review discussions
- Prepare, write, and review aggregate safety documents such as DSURs
- Review scientific literature and prepare written summaries supporting aggregate safety analyses
- Participate in safety data review, surveillance, signal detection, and signal management
- Present cases at safety management and safety review team meetings
- Co-lead safety surveillance and signal management meetings
- Participate in process improvement projects related to medical review, safety surveillance, and pharmacovigilance compliance
- Assist in developing and maintaining pharmacovigilance processes, SOPs, work instructions, safety management plans, and safety surveillance plans
- Develop safety presentations for independent Data Monitoring Committee meetings
- Collaborate with the Medical Review Lead and other physicians on case review and unified medical review approaches
- Lead epidemiology projects relevant to safety and pharmacovigilance
- Ensure activities meet quality, accuracy, timeliness, and global regulatory requirements
- Provide medical safety strategy and execute benefit-risk management strategies
- Provide safety input to clinical development plans and responses to health authority or ethics committee queries
- Develop safety risk language and risk management strategies
- Support pre-filing safety activities, integrated safety reviews, and safety-focused publications
- Perform other duties as assigned
- Report to the Senior Vice President of Drug Safety and Pharmacovigilance, with a dotted-line relationship to the Medical Review Lead
Requirements
What you’ll need- MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry
- A degree in epidemiology (Masters in Public Health, Masters of Science in Epidemiology, Doctor of Philosophy in Epidemiology, or Doctor of Public Health) or several years’ working knowledge in Epidemiology/Pharmacoepidemiology is highly preferred
- Working experience / proficiency in Argus global safety database and medical review activities
- Working experience in safety surveillance and signal detection activities
- 2-3 years Medical Device safety experience is a strong preference
- Knowledge of global pharmacovigilance regulations, including EMA and FDA requirements
- Excellent analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to motivate teams and collaborate effectively across functions
Benefits
Comp & perks- Market competitive compensation and benefits package
- Performance bonus
- Equity grant opportunities
- Health benefits
- Welfare benefits
- Retirement benefits
- Unlimited PTO
- Two, one-week company-wide shutdowns each year
- Professional development opportunities
- Remote working environment with frequent in-person meetings