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Medical Director, Pharmacovigilance, Drug Safety
Geron Corporation. Lead triage and medical oversight of individual case safety reports .
Posted 10/27/2026full-timeParsippany • New Jersey • United StatesLead💰 $230,000 - $270,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance and drug safety, including safety surveillance, signal detection, and benefit-risk assessment. Proficient in preparing aggregate safety reports and conducting medical reviews of individual case safety reports.
Highest-signal resume keywords
MD Or Internationally Recognized Medical Degree7 Years Pharmaceutical Or Biotechnology ExperienceSafety Surveillance And Signal DetectionICSR Triage And Medical ReviewGlobal PV Requirements Knowledge
ATS Keywords
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Hard Skills
Safety Data AnalysisBenefit-Risk AssessmentAggregate Safety Report PreparationClinical Relevance AssessmentData InterpretationSignal ManagementRisk ManagementProject ManagementMedical ReviewDocumentation Preparation
Soft Skills
Strong Medical And Scientific JudgmentEffective CommunicationCollaboration With Global TeamsAnalytical Skills
Industry Keywords
PharmacovigilanceDrug SafetyClinical SafetyRegulatory Safety WritingFDAEMAMHRAPMDAICHGVP
About the role
Key responsibilities & impact- Lead triage and medical oversight of individual case safety reports
- Analyze complex safety data and synthesize clear assessments
- Prepare documentation for signal and benefit-risk assessment
- Lead preparation of periodic aggregate safety reports
- Partner across functions to advance patient safety and support global product lifecycle
- Conduct routine and ad hoc safety surveillance and signal detection
- Evaluate safety data trends and develop presentations, reports, and required documentation
- Drive signal assessment and benefit-risk evaluation and document recommendations
- Perform individual case safety report triage for seriousness, causality, expectedness, clinical significance, and reportability
- Complete medical review of ICSRs for clinical cohesiveness and company assessment
- Contribute safety content to protocols, investigator’s brochures, informed consent documents, risk management plans, health authority responses, and filing dossiers
- Represent PV & DS on study teams
- Support audits, inspections, continuous improvement of PV processes, and trainings
- Report to the Vice President, Pharmacovigilance & Drug Safety
- Perform other duties as assigned
Requirements
What you’ll need- MD or internationally recognized medical degree required
- 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
- 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
- Strong medical and scientific judgment
- 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
- Strong knowledge of global PV requirements including FDA, EMA, MHRA, PMDA, ICH, and GVP
- Ability to communicate complex issues clearly
- Ability to work effectively with remote partners on a global team
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Flexible spending accounts
- Disability insurance
- Supplemental health insurance
- 401(k) retirement savings plan
- Employee stock purchase plan
- Up to 160 hours of accrued vacation during each full year of employment
- 64 hours of sick leave
- 9 standard paid holiday days off
- Paid leave for certain life events