Senior PV Scientist
OR · On-site +1
The Opportunity As Praxis advances its pipeline and prepares for regulatory submissions, this ... Contribute to the development and evolution of PV SOPs, safety management plans, and database ...
Senior PV Scientist
OR · On-site +1
The Opportunity As Praxis advances its pipeline and prepares for regulatory submissions, this ... Contribute to the development and evolution of PV SOPs, safety management plans, and database ...
Senior PV Operations Specialist
Boston, MA · On-site
$116K - $143K/yr
Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings). * Collaborate with PV and other functionals to coordinate case management, aggregate ...
Senior PV Operations Specialist
Boston, MA · On-site
$116K - $143K/yr
Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings). * Collaborate with PV and other functionals to coordinate case management, aggregate ...
Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings). * Collaborate with PV and other functionals to coordinate case management, aggregate ...
Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings). * Collaborate with PV and other functionals to coordinate case management, aggregate ...
Provide oversight and ensure submission compliance with business partners, CROs and global ... Work with PV management and other cross functional team members to ensure PV compliance and ...
Provide oversight and ensure submission compliance with business partners, CROs and global ... Work with PV management and other cross functional team members to ensure PV compliance and ...
Provide oversight and ensure submission compliance with business partners, CROs and global ... Work with PV management and other cross functional team members to ensure PV compliance and ...
Provide oversight and ensure submission compliance with business partners, CROs and global ... Work with PV management and other cross functional team members to ensure PV compliance and ...
PV Operations Specialist
Princeton, NJ · On-site
$85K - $115K/yr
The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in ... regulatory submissions, hands-on work within the safety database, and CAPA management and ...
PV Operations Specialist
Princeton, NJ · On-site
$85K - $115K/yr
The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in ... regulatory submissions, hands-on work within the safety database, and CAPA management and ...
PV Operations Specialist
$85K - $115K/yr
The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in ... regulatory submissions, hands-on work within the safety database, and CAPA management and ...
PV Operations Specialist
$85K - $115K/yr
The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in ... regulatory submissions, hands-on work within the safety database, and CAPA management and ...
PV Operations Specialist
Princeton, NJ · On-site
$85K - $115K/yr
The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in ... regulatory submissions, hands-on work within the safety database, and CAPA management and ...
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PV Operations Specialist
Princeton, NJ · On-site
$85K - $115K/yr
The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in ... regulatory submissions, hands-on work within the safety database, and CAPA management and ...
Senior PV Scientist
$136K - $156K/yr
The Opportunity As Praxis advances its pipeline and prepares for regulatory submissions, this ... Contribute to the development and evolution of PV SOPs, safety management plans, and database ...
Senior PV Scientist
$136K - $156K/yr
The Opportunity As Praxis advances its pipeline and prepares for regulatory submissions, this ... Contribute to the development and evolution of PV SOPs, safety management plans, and database ...
Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and ... Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent ...
Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and ... Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent ...
... submission to regulatory authorities, including, among others, Periodic Safety Update Reports ... Manage teams of PV Scientists and Fellows, as well as the Aggregate report specialists
... submission to regulatory authorities, including, among others, Periodic Safety Update Reports ... Manage teams of PV Scientists and Fellows, as well as the Aggregate report specialists
Manage DSI's Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV ... submission to Health Authorities and License Partners, Reconciliation with License Partners ...
Manage DSI's Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV ... submission to Health Authorities and License Partners, Reconciliation with License Partners ...
... submission to Health Authorities and License Partners, Reconciliation with License Partners ... Manage quality, efficiency, and resources for PV service providers/vendors Measure and monitor ...
... submission to Health Authorities and License Partners, Reconciliation with License Partners ... Manage quality, efficiency, and resources for PV service providers/vendors Measure and monitor ...
Manage DSI's Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV ... submission to Health Authorities and License Partners, Reconciliation with License Partners ...
Manage DSI's Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV ... submission to Health Authorities and License Partners, Reconciliation with License Partners ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
Quick apply
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
Quick apply
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and ... Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent ...
Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and ... Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
The Role The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor ... Ensures processes are adhered to that support on time and appropriate ICSR submissions * Provides ...
Pv Submission Manager information
What are the key skills and qualifications needed to thrive as a PV Submission Manager, and why are they important?
To thrive as a PV Submission Manager, you need an in-depth understanding of pharmacovigilance regulations, submission processes, and a background in life sciences or pharmacy. Familiarity with safety databases (such as Argus or ArisGlobal), regulatory submission portals (like EudraVigilance), and relevant global standards is crucial. Strong organizational skills, attention to detail, and effective cross-functional communication set outstanding candidates apart. These competencies ensure timely, compliant, and accurate safety data submissions, which are critical for patient safety and regulatory approval.
What is a PV Submission Manager?
A PV Submission Manager is a professional responsible for overseeing the preparation, coordination, and timely submission of pharmacovigilance (PV) documents and reports to regulatory authorities. They ensure that all required safety data, such as Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs), comply with global regulatory requirements. PV Submission Managers collaborate closely with regulatory, clinical, and safety teams to maintain compliance, manage submission timelines, and address any issues that arise during the submission process.
What are some common challenges faced by a Pv Submission Manager, and how can they be addressed?
A Pv Submission Manager often faces challenges such as coordinating across global teams, maintaining compliance with evolving regulatory requirements, and managing tight submission timelines. To address these, strong project management skills, proactive communication with cross-functional teams, and staying updated on regulatory changes are essential. Leveraging electronic submission tools and fostering a culture of continuous learning further help in overcoming these hurdles and ensuring timely, accurate submissions.
Job description
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
As Praxis advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor oversight, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The PV Scientist enables the PV Lead to focus on clinical safety strategy, regulatory submission activities, and labeling development by providing both strategic and operational support across safety activities.
Primary Responsibilities
- 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.
Qualifications and Key Success Factors
- 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.
About Praxis Precision Medicines
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Boston, MA, US
Year founded
2015