Associate Medical Director, Medical Safety

Responsibilities:

• Implement global safety strategy and monitor overall safety profile for investigational and marketed products throughout lifecycle.
• Generate pre- and post-marketing safety deliverables (signal detection, benefit-risk evaluation, risk management).
• Interface cross-functionally and with external Regulatory Authorities.
• Manage safety assessment activities: review aggregate safety analyses/scientific literature, prepare safety reports, and communicate changes in product risk profile.
• Provide Medical Safety/PV inputs to clinical development, investigator-sponsored programs, compassionate use, and disease monitoring programs; liaise with study and safety stakeholders (Clinical Sciences/Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs).
• Support global launch activities with PV/medical safety inputs.
• Prepare/review safety sections for clinical, regulatory, and scientific documents (protocols, consent forms, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts).
• Maintain Company Core Safety Information (CCSI) implementation across RSI/labeling; review relevant literature for signals.
• Conduct signal detection, evaluation, validation, and communicate safety assessments.
• Chair Safety Management Team (SMT); oversee preparation/review of aggregate safety reports (PSUR/PBRER, PADER, DSUR, IND Annual Reports, 6-month SUSAR line listings).
• Contribute to Risk Management Plans (RMPs); guide MedDRA/WHODrug coding.
• Ensure compliance with PV regulations/guidelines and support audits/inspections.
• Represent PV in cross-functional forums; contribute to PV KPIs; stay current on PV guidance.

Required:

• MD (or equivalent); medical licensure in at least one state preferred.
• Minimum 3 years Drug Safety/Pharmacovigilance or 3+ years clinical development.

Required Skills/Abilities:

• Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP).
• Working knowledge of safety databases (e.g., ARISg/ARGUS) and electronic data capture.
• MedDRA training and coding dictionary knowledge.
• Ability to manage multiple deadlines; strong written/oral communication and cross-functional teamwork.
• Computer literacy (Regulatory databases, Excel, PowerPoint, Word); some travel possible.

Benefits (US candidates):

• medical/dental/vision insurance, 401(k), flexible paid vacation; discretionary bonus/incentive and potential equity grants.