Associate Director Drug Safety — Remote/SD PV Leader

Iambic; San Diego (CA); Remote; USD 164,000 - 205,000; Full time

Benefits offered by this job

Competitive pay

Company paid healthcare

Flexible spend accounts

401K matching

Uncapped vacation

Onsite gym

Job summary

Iambic Therapeutics seeks an Associate Director, Drug Safety to lead pharmacovigilance activities and drive regulatory safety deliverables. You will oversee outsourced PV activities and collaborate with Quality, Clinical Operations, and Clinical Development to set up and run safety processes across development phases for oral oncology therapies.

The role supports inspection readiness, CAPAs, audits, and regulatory inspections, while mentoring junior Drug Safety staff in a dynamic, growing

Qualifications

• Bachelor's degree in nursing or pharmacy; advanced degree preferred.
• 10+ years in pharmacovigilance, drug safety, clinical science, or related environment with a Bachelor’s and 6–8 years with an advanced degree.
• Experience across 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, mentor junior Drug Safety staff, contractors, consultants, and vendor personnel.
• Knowledge of FDA, EMA, ICH, GCP, and GVP requirements.
• Oncology phase I to III experience preferred.

Responsibilities

• Provide day-to-day oversight of SAE processing activities (internal and external).
• Coordinate reconciliation of safety information across clinical databases and partners.
• Monitor vendor performance and track actions, issues and CAPAs.
• Support safety databases implementation, maintenance, and enhancement.
• Contribute to aggregate safety reports and regulatory submissions.
• Coordinate safety data deliverables for regulatory requests.
• Review safety data and identify emerging trends.
• Co-author and maintain Safety Management Plans and other inspection readiness documents.
• Support CAPAs, change controls, audits, and regulatory inspections.

Skills

Pharmacovigilance

Safety surveillance

Regulatory knowledge

Training / mentoring

Education

Bachelor's in Nursing or Pharmacy

Advanced degree preferred (PharmD, MSN, MPH)

Tools

Safety databases

Job description

Iambic Therapeutics seeks an Associate Director, Drug Safety to lead pharmacovigilance activities and drive regulatory safety deliverables. You will oversee outsourced PV activities and collaborate with Quality, Clinical Operations, and Clinical Development to set up and run safety processes across development phases for oral oncology therapies.

The role supports inspection readiness, CAPAs, audits, and regulatory inspections, while mentoring junior Drug Safety staff in a dynamic, growing