PV Scientist
Edgewise Therapeutics
August 21, 2026
Remote friendly (United States)
United States
Operations
Drug Safety & Pharmacovigilance Scientist
Responsibilities:
- Perform safety assessments for the company’s asset across all indications; work with PV MDs on signal management, safety, and benefit-risk evaluations.
- Compile aggregate safety reports (e.g., DSUR, PBRER, PSUR), including safety database requests and planning to meet regulatory timelines.
- Compile safety information for clinical overviews, regulatory responses, post-marketing safety assessments, risk management plans, labeling justifications, CCSI development, IB updates, label updates, and clinical safety summaries.
- Collaborate with the safety physician for signal detection and benefit-risk assessment.
- Manage literature review plans for marketed and investigational medicinal products.
- Plan and execute routine and ad-hoc safety governance meetings.
- Represent PV in cross-functional clinical programs and registration activities.
- Partner with CROs and clinical teams to ensure protocol designs support timely SAE processing and global regulatory compliance.
- Oversee SAE reconciliation between clinical and safety databases per SOPs.
- Collaborate with Clinical Ops, Data Mgmt, CRO, and study teams on safety data tables/listings and safety reporting plans (SRP).
- Lead/assist in developing and supporting PV policies, SOPs, and tools.
- Project manage and author safety documents with safety physicians.
Qualifications & Skills:
- PharmD, PhD, RN, RPH, MS, or MPH required.
- 7+ years relevant medical/scientific/clinical/pharmaceutical experience, including drug safety data analysis.
- Signal detection experience; strong medical/scientific data analysis and interpretation.
- Experience with aggregate safety reports and safety assessments (e.g., IB, DSUR, PBRER).
- Knowledge of PV regulations/guidance (US and global) and PV safety surveillance.
- Experience with MedDRA coding/search strategies.
- Strong Microsoft Office and safety database proficiency.
- Excellent oral/written communication (medical/scientific writing); cross-functional collaboration and independent work.
- Ability to raise issues, propose solutions, and facilitate analysis/problem solving.
Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) match, paid time off.
Application instructions:
- No deadline; employer accepts applications on an ongoing basis.
Responsibilities:
- Perform safety assessments for the company’s asset across all indications; work with PV MDs on signal management, safety, and benefit-risk evaluations.
- Compile aggregate safety reports (e.g., DSUR, PBRER, PSUR), including safety database requests and planning to meet regulatory timelines.
- Compile safety information for clinical overviews, regulatory responses, post-marketing safety assessments, risk management plans, labeling justifications, CCSI development, IB updates, label updates, and clinical safety summaries.
- Collaborate with the safety physician for signal detection and benefit-risk assessment.
- Manage literature review plans for marketed and investigational medicinal products.
- Plan and execute routine and ad-hoc safety governance meetings.
- Represent PV in cross-functional clinical programs and registration activities.
- Partner with CROs and clinical teams to ensure protocol designs support timely SAE processing and global regulatory compliance.
- Oversee SAE reconciliation between clinical and safety databases per SOPs.
- Collaborate with Clinical Ops, Data Mgmt, CRO, and study teams on safety data tables/listings and safety reporting plans (SRP).
- Lead/assist in developing and supporting PV policies, SOPs, and tools.
- Project manage and author safety documents with safety physicians.
Qualifications & Skills:
- PharmD, PhD, RN, RPH, MS, or MPH required.
- 7+ years relevant medical/scientific/clinical/pharmaceutical experience, including drug safety data analysis.
- Signal detection experience; strong medical/scientific data analysis and interpretation.
- Experience with aggregate safety reports and safety assessments (e.g., IB, DSUR, PBRER).
- Knowledge of PV regulations/guidance (US and global) and PV safety surveillance.
- Experience with MedDRA coding/search strategies.
- Strong Microsoft Office and safety database proficiency.
- Excellent oral/written communication (medical/scientific writing); cross-functional collaboration and independent work.
- Ability to raise issues, propose solutions, and facilitate analysis/problem solving.
Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) match, paid time off.
Application instructions:
- No deadline; employer accepts applications on an ongoing basis.