Senior Pharmacovigilance Scientist: Safety Signals & Trials

Edgewise Therapeutics; Boulder (CO); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Health benefits

Discretionary bonus

Stock option grants

Stock purchase plan

401(k) with match

Paid time off

Job summary

Edgewise Therapeutics is seeking a Safety Scientist to lead safety assessments across assets, collaborating with PV MDs and Clinical teams to manage signals and safety evaluations.

The ideal candidate has 7+ years in medical/pharmaceutical safety, strong data analysis, and proven ability to draft regulatory responses, with excellent written and verbal communication in a fast-paced environment.

Qualifications

• Healthcare professional or advanced degree required.
• 7+ years in medical/scientific/pharmaceutical roles with drug safety experience.
• Experience in signal detection and analysis of medical data.
• Experience in safety data analysis and writing safety assessments (IB, DSUR, PBRER).
• Strong written and oral communication; cross-functional collaboration.
• Knowledge of US/global PV regulations and surveillance practices.
• Experience with MedDRA and safety database usage.

Responsibilities

• Compile aggregate safety reports (DSUR, PBRER, PSUR) and manage safety inputs.
• Prepare safety information for clinical overviews and regulatory responses.
• Lead PV activities and governance meetings with stakeholders.
• Collaborate with PV, Clinical Development, Medical Affairs, and Regulatory teams.
• Coordinate safety data from interventional/non-interventional trials and safety plans.
• Develop and maintain PV policies, SOPs, and tools as needed.
• Draft safety documents with safety physicians and manage risk assessments.

Skills

Signal detection

Safety data analysis

Medical writing

Cross-functional teamwork

Communication skills

Education

Healthcare professional or advanced degree (PharmD, PhD, RN, RPH, MS, MPH)

Tools

MedDRA coding

Safety databases

Microsoft Office

Job description

Edgewise Therapeutics is seeking a Safety Scientist to lead safety assessments across assets, collaborating with PV MDs and Clinical teams to manage signals and safety evaluations.

The ideal candidate has 7+ years in medical/pharmaceutical safety, strong data analysis, and proven ability to draft regulatory responses, with excellent written and verbal communication in a fast-paced environment.