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Iambic Therapeutics

Associate Director, Drug Safety

Iambic Therapeutics

. Oversee outsourced pharmacovigilance activities and contribute to regulatory and safety deliverables .

Posted 9/16/2026full-timeRemote • United StatesSenior💰 $164,000 - $205,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in pharmacovigilance and drug safety, with a strong understanding of regulatory requirements and safety data management. Capable of overseeing safety processes, mentoring staff, and contributing to regulatory submissions and safety reports.

Highest-signal resume keywords
Pharmacovigilance ExperienceSafety Database ProficiencyMedDRA and WHODrug KnowledgeRegulatory Compliance ExpertiseOncology Development Experience

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
PharmacovigilanceDrug SafetyClinical ScienceSafety Data ManagementAggregate Safety ReportsSAE ProcessingCAPAsChange ControlsRegulatory SubmissionsSafety Management Plans
Soft Skills
Interpersonal SkillsProfessionalismCommunication SkillsTraining and Mentoring
Tools & Technologies
Safety Databases
Certifications & Qualifications
Bachelor's Degree in Nursing or PharmacyAdvanced Degree (PharmD, MSN, MPH)
Industry Keywords
FDA RegulationsEMA GuidelinesICH GuidelinesGCPGVPOncology Phase I to III

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Oversee outsourced pharmacovigilance activities and contribute to regulatory and safety deliverables
  • Work collaboratively with Quality, Clinical Operations, and Clinical Development to establish and execute safety processes
  • Provide day-to-day oversight of internally and externally performed SAE processing
  • Coordinate reconciliation of safety information across clinical databases and business partners
  • Monitor vendor performance through compliance trends and review of operational deliverables
  • Track action items, issues, and corrective actions
  • Support implementation, maintenance, and enhancement of safety databases
  • Contribute to aggregate safety reports and safety sections of clinical, safety, and regulatory documents
  • Coordinate safety data deliverables for aggregate reports, regulatory submissions, and health authority requests
  • Review individual and aggregate safety data and identify emerging trends
  • Co-author and maintain controlled documents, Safety Management Plans, Safety Data Exchange Agreements, and other inspection-readiness documents
  • Support CAPAs, change controls, audits, and regulatory inspections
  • Perform responsibilities across all phases of development for oral small-molecule oncology therapies
  • Report to the Head of Safety

Requirements

What you’ll need
  • Bachelor's degree in nursing or pharmacy required
  • Advanced degree such as PharmD, MSN, MPH, or equivalent preferred
  • At least 10 years of combined experience in pharmacovigilance, drug safety, clinical science, or a related environment with a bachelor's degree
  • 6–8 years of relevant experience with an advanced degree
  • Related experience across both safety science/surveillance and pharmacovigilance operations preferred
  • Strong understanding of MedDRA and WHODrug dictionaries
  • Proficiency in the use of safety databases
  • Excellent interpersonal skills and professionalism
  • Written and verbal proficiency with ability to communicate clinical topics succinctly and clearly
  • Ability to train and mentor junior Drug Safety staff, contractors, consultants, and vendor personnel
  • Knowledge of applicable global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GCP, and GVP requirements
  • Oncology phase I to III experience preferred
  • Must be currently authorized to work in the United States
  • Must disclose whether visa sponsorship is currently or prospectively required

Benefits

Comp & perks
  • Company-paid healthcare
  • Flexible spending accounts
  • Voluntary life insurance
  • 401(k) matching
  • Uncapped vacation
  • Onsite gym
  • Dining at the facility
  • Flexible remote work arrangement / option to work from San Diego headquarters