Medical Director, Pharmacovigilance & Drug Safety

Geron Corporation•Parsippany-Troy Hills, NJ

15d•$230,000 - $270,000

About The Position

The Medical Director, Pharmacovigilance & Drug Safety (PV & DS) leads triage and medical oversight of individual case safety reports, analyzes complex safety data, and synthesizes findings into clear assessments. The role prepares documentation for signal and benefit-risk assessments, leads periodic aggregate safety report preparation, and partners across functions to advance patient safety and support the global product lifecycle. The Medical Director reports to the Vice President, Pharmacovigilance & Drug Safety. The role conducts safety surveillance and signal detection, evaluates safety trends, assesses individual cases, and develops recommendations for PV & DS review, safety governance, and cross-functional teams. It contributes safety content to product and regulatory documents, represents PV & DS on study teams, and supports audits, inspections, process improvement, and training.

Requirements

MD or internationally recognized medical degree required.
At least 7 years of pharmaceutical or biotechnology experience in drug safety, clinical safety, medical safety, regulatory safety writing, or related pharmaceutical/biotechnology experience.
Demonstrated experience with safety surveillance, signal detection, ICSR triage and medical review, aggregate safety report preparation, and benefit-risk assessment.
Experience applying principles and techniques of data analysis, interpretation, and clinical relevance assessment.
Strong medical and scientific judgment and 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 the product lifecycle.
Excellent project management and analytical skills, with the ability to communicate complex issues simply and coordinate plans to resolve issues and mitigate risks.
Strong knowledge of global pharmacovigilance requirements, including FDA, EMA, MHRA, PMDA, ICH, and GVP.
Collaborative, quality-focused, and accountable work style; ability to influence without direct authority and drive timely safety decisions.
Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient, and to work effectively with remote partners on a global team.

Nice To Haves

Two or more years of clinical experience, with strong clinical knowledge and medical practice experience preferred.

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 as clear recommendations for the PV & DS review team, safety governance, and cross-functional teams.
Perform individual case safety report triage, assessing seriousness, causality, expectedness, clinical significance, and reportability.
Perform medical review of individual case safety reports for clinical cohesiveness and the Company’s assessment.
Lead preparation of periodic aggregate reports.
Contribute safety content to applicable documents, including protocols, investigator’s brochures, 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 training.
Perform other duties as assigned.