PV Scientist

Scorpion Therapeutics; United States; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health benefits

Discretionary bonus plan

Stock option grants

Stock purchase plan

401(k) match

Paid time off

Job summary

Scorpion Therapeutics is seeking a Drug Safety & Pharmacovigilance Scientist to lead safety assessments across indications, manage signal detection, and compile DSURs/PBRERs with regulatory timelines.

The role requires 7+ years in medical/scientific roles with drug safety analytic experience, and strong writing and cross-functional collaboration skills in a fast-paced setting.

Qualifications

• Advanced clinical or scientific degree required (PharmD/PhD/RN/RPH/MS/MPH).
• 7+ years in medical/scientific/pharmaceutical roles with drug safety data analysis.
• Experience with aggregate safety reports (IB/DSUR/PBRER) and safety assessments.
• Knowledge of US and global PV regulations and coding standards (MedDRA).

Responsibilities

• Perform safety assessments for the company’s asset across all indications; collaborate on signal management and benefit-risk evaluations.
• Compile aggregate safety reports (DSUR, PBRER, PSUR) and coordinate safety database requests.
• Prepare safety information for clinical overviews, regulatory responses, and labeling justifications.
• Collaborate with safety physicians on signal detection and benefit-risk assessment.
• Oversee literature reviews for marketed and investigational products.
• Plan and run 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 timely SAE processing and global compliance.
• Oversee SAE reconciliation between clinical and safety databases per SOPs.
• Collaborate on safety data tables/listings and SRP with study teams.
• Lead or assist in developing PV policies, SOPs, and tools.
• Project manage and author safety documents with safety physicians.

Skills

Signal detection

Data analysis

Medical writing

Cross-functional collaboration

Independent problem solving

Education

PharmD

PhD

RN

RPH

MS

MPH

Tools

MedDRA coding

Job description

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.