Associate Medical Director (Medical Safety)

Location: Remote for US-based candidates only; Palo Alto, California

Base salary for US-based candidates: $212,000–$318,000 per year

Company

Global biopharmaceutical organization developing medicines for serious diseases, with research, manufacturing, and commercial operations across multiple countries.

What you will do

• Implement global medical safety and pharmacovigilance strategies for investigational and marketed products throughout their lifecycles.
• Conduct signal detection, aggregate safety analyses, benefit-risk evaluations, and risk management activities.
• Prepare and review safety content for clinical, regulatory, and scientific documents, including NDA/BLA, MAA, CTD, PSUR/PBRER, DSUR, and other reports.
• Lead Safety Management Teams and represent pharmacovigilance in cross-functional forums involving clinical, regulatory, commercial, and external stakeholders.
• Oversee Company Core Safety Information, product labeling, adverse-event and drug coding guidance, and consistent communication of product risks.
• Support inspection readiness, audits, regulatory inspections, and compliance with global pharmacovigilance regulations and quality standards.

Requirements

• MD or equivalent required; medical licensure in at least one state is preferred.
• At least 3 years of drug safety/pharmacovigilance or clinical development experience.
• Knowledge of global pharmacovigilance regulations, GVP, and guidance from authorities including FDA, EMA, ICH, and CIOMS.
• Experience with safety databases such as ARISg or Argus, electronic data capture systems, MedDRA, and WHO Drug coding dictionaries.
• Knowledge of the drug development process and ability to manage multiple deadlines in a fast-paced environment.
• Excellent written and verbal communication, initiative, independence, organization, and cross-functional collaboration skills; some national or international travel may be required.

Nice to have

• Clinical research or fellowship training in internal medicine, neuroscience, hematology/oncology, or another relevant specialty.
• Experience participating in pharmacovigilance audits and regulatory authority inspections.

Culture & Benefits

• Patient-focused and science-driven work on medicines for serious diseases and limited or underserved therapeutic needs.
• Remote work arrangement for US-based candidates.
• Eligible US employees may receive annual bonus or incentive compensation and equity grants.
• Benefits may include medical, dental, and vision insurance, 401(k) retirement savings, and flexible paid vacation.