Position SummaryThe Medical Director, Pharmacovigilance & Drug Safety (PV & DS) will lead triage and medical oversight of individual case safety reports, analyze complex safety data and synthesize into clear assessments, prepare documentation for signal and benefit-risk assessment, lead preparation of periodic aggregate safety reports, and partner across functions to advance patient safety and support global product lifecycle.
The Medical Director will report to the Vice President, Pharmacovigilance & Drug Safety.
Primary Responsibilities - Conduct routine and ad hoc safety surveillance and signal detection, evaluate safety data trends, and develop presentations, reports, or other required documentation
- Drive signal assessment and benefit-risk evaluation and document findings into clear recommendations for PV & DS review team, safety governance, and cross-functional teams
- Perform individual case safety report triage for assessments of seriousness, causality, expectedness, clinical significance, and reportability
- Complete medical review of ICSRs for clinical cohesiveness and Company assessment
- Lead periodic aggregate report preparation
- Contribute safety content to applicable documents including protocols, investigator's brochure, informed consent, risk management plans, health authority responses, and filing dossiers
- Represent PV & DS on study teams and support timely, scientifically grounded decisions
- Support audits, inspections, and continuous improvement of PV processes and trainings
- Perform other duties as assigned
Competencies - Strong medical and scientific judgment and the ability to interpret complex clinical and safety data
- Deep expertise in safety surveillance, signal management, ICSR triage and review, periodic aggregate data analysis and report preparation, benefit-risk assessment, and risk management across product lifecycle
- Excellent project management and analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks
- Strong knowledge of global PV requirements including FDA, EMA, MHRA, PMDA, ICH, and GVP
- Collaborative, quality-focused, and accountable work style with the ability to influence without direct authority and drive timely safety decisions
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient and effectively work with remote partners on a global team
Experience- MD or internationally recognized medical degree required
- A minimum of 7 years of pharmaceutical or biotechnology experience in drug safety, clinical safety, medical safety, regulatory safety writing, or related pharmaceutical/biotechnology experience
- 2 or more years of clinical experience preferred, with strong clinical knowledge and medical practice experience
- Demonstrated experience with safety surveillance, signal detection, ICSR triage/medical review, aggregate safety report preparation, and benefit-risk assessment
- Experience applying principles and techniques of data analysis, interpretation, and clinical relevance assessment
Benefit Statement:
All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees.
Salary Statement:
Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background.
General Salary Range: $230,000 to $270,000
