Associate Medical Director, Medical Safety

Location: Remote/home-based role associated with Cambridge, UK; London, UK; Carlsbad, California; Palo Alto, California; and Philadelphia, Pennsylvania.

Salary: $212,000–$318,000 annual base pay for US-based candidates, with potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing and commercializing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

• Implement global medical safety and pharmacovigilance strategies for assigned investigational and marketed products throughout their lifecycles.
• Evaluate aggregate safety data, scientific literature, safety signals, trends, and benefit-risk profiles.
• Prepare and review safety content for protocols, clinical and regulatory documents, submissions, labeling, and scientific publications.
• Oversee and sign pre- and post-marketing aggregate safety reports, including PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, and SUSAR line listings.
• Chair Safety Management Teams and communicate product risk-profile changes to internal stakeholders and regulatory authorities.
• Collaborate with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, and commercial teams.

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.
• Working knowledge of global PV regulations, GVP, CIOMS, EMA, FDA, and ICH requirements.
• Experience with safety databases such as ARISg or Argus, electronic data capture systems, MedDRA, and WHO Drug coding dictionaries.
• Knowledge of drug development, safety assessment, aggregate reporting, risk management, and regulatory inspections.
• Excellent written and oral communication, cross-functional collaboration, organization, initiative, and ability to manage multiple deadlines.

Nice to have

• Clinical research or fellowship training in internal medicine, neuroscience, hematology/oncology, or another relevant specialty.
• Experience with PV audits and active participation in regulatory authority inspections.
• Some national or international travel availability.

Culture & Benefits

• Remote/home-based work arrangement.
• Opportunity to support medicines for patients with serious diseases and limited treatment options.
• Potential annual cash bonus or incentive compensation and discretionary equity grants.
• US benefits may include medical, dental, and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation.
• Work in a global organization with research, development, manufacturing, and employees across multiple countries.