Pharmacovigilance Scientist
Horsham, PA ยท On-site
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report ... Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR ...
Horsham, PA ยท On-site
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report ... Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR ...
Horsham, PA ยท On-site
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report ... Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR ...
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report ... Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR ...
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report ... Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR ...
Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks * Manage literature ...
Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks * Manage literature ...
Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER) * Experience with preparation of responses to Regulatory Authorities, preferred experience with IND ...
Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER) * Experience with preparation of responses to Regulatory Authorities, preferred experience with IND ...
Cambridge, MA ยท On-site +1
$210K - $235K/yr
Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER) * Experience with preparation of responses to Regulatory Authorities, preferred experience with IND ...
Cambridge, MA ยท On-site +1
$210K - $235K/yr
Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER) * Experience with preparation of responses to Regulatory Authorities, preferred experience with IND ...
Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks * Manage literature ...
Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks * Manage literature ...
Foster City, CA ยท Hybrid
$226K - $292K/yr
Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Quick apply
Foster City, CA ยท Hybrid
$226K - $292K/yr
Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Key Responsibilities Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). Provide strategic oversight of roles ...
Key Responsibilities Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). Provide strategic oversight of roles ...
Foster City, CA ยท Hybrid
$226K - $292K/yr
Key Responsibilities Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). Provide strategic oversight of roles ...
Foster City, CA ยท Hybrid
$226K - $292K/yr
Key Responsibilities Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). Provide strategic oversight of roles ...
$150K - $250K/yr
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related ...
Quick apply
$150K - $250K/yr
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related ...
Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Quick apply
Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Princeton, NJ ยท On-site
$150K - $250K/yr
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related ...
Princeton, NJ ยท On-site
$150K - $250K/yr
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related ...
Foster City, CA ยท On-site
$226K - $292K/yr
Lead endtoend programming strategy and execution for compoundlevel aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Foster City, CA ยท On-site
$226K - $292K/yr
Lead endtoend programming strategy and execution for compoundlevel aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Foster City, CA ยท On-site
$226K - $292K/yr
Lead end-to-end programming strategy and execution for compound-level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Foster City, CA ยท On-site
$226K - $292K/yr
Lead end-to-end programming strategy and execution for compound-level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Princeton, NJ ยท On-site
$150K - $250K/yr
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related ...
Quick apply
Princeton, NJ ยท On-site
$150K - $250K/yr
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related ...
Foster City, CA ยท On-site
$226K - $292K/yr
Lead endtoend programming strategy and execution for compoundlevel aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Foster City, CA ยท On-site
$226K - $292K/yr
Lead endtoend programming strategy and execution for compoundlevel aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI). * Provide strategic oversight of roles, responsibilities ...
Support to prepare periodic aggregate reports (PSUR/PBRER/DSUR) and Risk Management Plan Minimum Qualifications & Experience: Bachelor of pharmacy/nursing/medicine/biology or a related major. A ...
Support to prepare periodic aggregate reports (PSUR/PBRER/DSUR) and Risk Management Plan Minimum Qualifications & Experience: Bachelor of pharmacy/nursing/medicine/biology or a related major. A ...
OR ยท On-site
Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) * Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.) * Contribute to signal detection and risk management ...
Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) * Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.) * Contribute to signal detection and risk management ...
Quick apply
Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) * Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.) * Contribute to signal detection and risk management ...
Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) * Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.) * Contribute to signal detection and risk management ...
Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) * Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.) * Contribute to signal detection and risk management ...
$5.29 - $6.97
0% of jobs
$6.97 - $8.65
0% of jobs
$8.65 - $10.34
0% of jobs
$10.34 - $12.02
0% of jobs
$12.02 - $13.70
0% of jobs
$13.70 - $15.38
0% of jobs
$16.33 is the 25th percentile. Wages below this are outliers.
$15.38 - $17.07
44% of jobs
The median wage is $17.45 / hr.
$17.07 - $18.75
25% of jobs
$19.23 is the 75th percentile. Wages above this are outliers.
$18.75 - $20.43
21% of jobs
$20.43 - $22.12
6% of jobs
$22.12 - $23.80
4% of jobs
$5
$18
$23
| Aspect | Psur Aggregate Report | Psur Data Analyst |
|---|---|---|
| Required Credentials | Typically no specific certifications, but familiarity with PSUR reporting standards | Often requires a degree in data analysis, healthcare, or related fields; certifications like CAP or PCAP are common |
| Work Environment | Regulatory or pharmaceutical settings, focusing on report compilation | Data analysis departments within pharma or healthcare companies, working with large datasets |
| Employer & Industry Usage | Used by regulatory agencies and pharmaceutical companies for safety reporting | Employed by pharma companies, CROs, or healthcare organizations for data interpretation |
The Psur Aggregate Report focuses on compiling and submitting safety data summaries for regulatory review, while the Psur Data Analyst interprets and analyzes the underlying data to support safety assessments. Both roles are integral to pharmacovigilance but differ in scope and responsibilities.

Contractor
Posted 14 days ago
Summary:
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report writing. He/she will contribute or will be responsible for report writing and/or report ownership related to core safety deliverables including scheduled and ad hoc post-marketing aggregate reports.
Daily activities involve database searching, aggregate safety analysis and case level review, writing, planning, conducting meetings, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders such as safety physicians, and a vendor. The Scientist must be able to work on multiple projects simultaneously and prioritize tasks.
Responsibilities:
Scientist would be responsible to contribute to or serve as report owner for scheduled and non-scheduled post-marketing safety reports and other deliverables as applicable.
Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports.
Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labeling support documents.
Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate
Initiate/conduct searches of internal and external databases
Perform aggregate safety analysis and case level review Present results at Safety Management Team meetings as needed
Author/contribute to the preparation of core safety deliverables
Partner with vendor to develop reports/deliverables
Comply with processes and ensure appropriate documentation
Utilize technical skills and programs to analyze and organize data (e.g., Excel pivot tables, SAS JMP)
Adhere to report timelines and escalate issues to management as appropriate
Qualifications/Experience Required
Bachelor s degree in health or biomedical science (3+ years industry experience or equivalent) or
Advanced degree preferred in health or biomedical science (2+ years industry experience or equivalent)
Clinical/medical writing and/or PV experience
Strong English verbal and written communication skills
Strongly Preferred:
Aggregate safety report writing and aggregate safety analysis
Project management of safety/regulatory documents
Awareness of applicable regulations and guidance related to post-marketing aggregate safety requirements
Experience using Microsoft word templates
Bachelor s degree in health or biomedical science (3+ years industry experience or equivalent) or
Advanced degree preferred in health or biomedical science (2+ years industry experience or equivalent)
All your information will be kept confidential according to EEO guidelines.