Praxis logo
Praxis

Focused patient recruitment.

Senior PV Scientist

GeneralGeneralFull TimeRemoteSeniorTeam 11-50Since 2002H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

105 days ago

Salary

$136K - $156K / year

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Senior PV Scientist

Praxis

• Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones. Proactively identify and resolve operational gaps before they become compliance risks. • Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. Ensure quality, timeliness, and regulatory compliance at all times. • Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations. Lead or support implementation of new safety tools (e.g., signal detection platforms, monitoring systems) to strengthen proactive surveillance. • Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings. Author signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity. • Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensure TMF documentation is complete, accurate, and inspection ready. Maintain compliance with global safety reporting requirements. • Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality to ensure aligned safety processes, including call center setup, partner safety data exchange, and commercialization readiness activities. • Ensure safety data exchange complies with partner agreements. Author searches for strategies for regulatory queries and internal requests. Maintain rigorous documentation standards to support inspections and audits.

Job 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 (clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, 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.

Related Categories

Related Job Pages

More General Jobs

Full TimeRemoteTeam 201-500Since 2016H1B Sponsor

• Engage with KOLs and external experts to discuss clinical data, emerging research, and disease-state insights • Support investigator-initiated and company-sponsored studies and represent the company at scientific meetings and congresses • Deliver clear, balanced scientific presentations and communicate field insights to internal stakeholders • Summarize key scientific updates and competitive intelligence to inform medical strategy and evidence-generation plans • Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, and Commercial teams to support clinical trial feasibility, investigator identification, and educational initiatives • Ensure all activities comply with SOPs, PhRMA Code, and global regulatory requirements while staying current on evolving oncology research • Contribute to internal training, medical planning, and continuous improvement of field processes.

United States
$192.8K - $264K / year

• Perform detailed title searches from sovereignty of the soil to present for properties across Texas. • Examine deeds, mortgages, easements, liens, judgments, tax records, plats, and other related documents. • Compile and prepare comprehensive title abstracts, run sheets, and title reports. • Verify legal descriptions and chain of title accuracy. • Identify title defects and provide clear documentation or recommendations for resolution. • Communicate professionally with title examiners, underwriters, attorneys, and landmen. • Utilize county clerk records, online databases, and abstract plants efficiently. • Maintain accuracy, timeliness, and confidentiality in all title research activities.

Texas
Medsien logo

Enrollment Specialist, Certified Medical Assistant

Medsien

The only Remote Care Management that everyone loves!

General105 days ago
Full TimeRemoteTeam 11-50H1B No Sponsor

• Educate and enroll eligible patients from our established clinic partnerships • Connect with eligible patients through outbound calls, resulting in enrollments to achieve your weekly goals • Help patients navigate and enroll in CCM and RPM programs to better their health and achieve their wellness goals

United States
Light Counseling logo

Licensed Mental Health Clinician, Alabama

Light Counseling

Clinically Excellent - Distinctly Christian

General106 days ago
ContractRemoteTeam 51-200H1B No Sponsor

• Provide remote counseling services to children, adolescents, adults, couples, families, and groups. • Collaborate with clients to identify concerns, define counseling goals, and develop actionable treatment plans. • Maintain accurate and timely clinical documentation in compliance with all state, federal, and company policies (i.e., HIPAA). • Participate in ongoing professional development through workshops, meetings, and training opportunities. • Integrate Christian faith and psychological best practices in therapy as appropriate. • Refer clients to other resources or specialists as needed. • Engage in occasional community outreach or ministry initiatives relevant to Light Counseling’s mission. • Provide clinical supervision or mentorship to interns and residents (if qualified).

Alabama