Associate Director, PV Scientist
Praxis
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $136,000 - $156,000 per year
Job Level
About the role
- Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones.
- Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement.
- Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations.
- Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings.
- Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials.
- Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality.
Requirements
- Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.
- Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.
- At least 1 year of clinical trial experience highly desirable.
- Experience with regulatory filings (INDs, NDAs, MAAs).
- Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.
- Experience in individual case safety reporting, aggregate reporting, signal detection, risk management planning, and PV SOP development.
- Experience implementing safety databases and signal detection tools preferred.
- Familiarity with MedDRA and WHO-Drug coding.
- Excellent written and verbal communication skills.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
- 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilanceclinical trial experienceregulatory filingsindividual case safety reportingaggregate reportingsignal detectionrisk management planningPV SOP developmentsafety database implementationMedDRA coding
Soft Skills
communication skillscollaborationprocess improvementoversightgovernance
Certifications
NurseNurse PractitionerPharmacistAllied Health Professional