Pharmacovigilance Scientist
Horsham, PA · 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 · 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 · 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 · 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 · 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 ...
Foster City, CA · Hybrid
$215K - $230K/yr
Facilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etc * Represent Medical Safety Science in assigned clinical study team meetings for Mirum products * Support the Sr. ...
Foster City, CA · Hybrid
$215K - $230K/yr
Facilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etc * Represent Medical Safety Science in assigned clinical study team meetings for Mirum products * Support the Sr. ...
Foster City, CA · On-site
$215 - $230/hr
Facilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etc * Represent Medical Safety Science in assigned clinical study team meetings for Mirum products * Support the Sr. ...
New
Foster City, CA · On-site
$215 - $230/hr
Facilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etc * Represent Medical Safety Science in assigned clinical study team meetings for Mirum products * Support the Sr. ...
New
$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 ...
DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) * GVP Guidelines * Signal Management * Benefit-Risk ... Experience with DSURs, PSURs/PBRERs, and aggregate safety reports. * Strong knowledge of ICH E2F ...
Quick apply
DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) * GVP Guidelines * Signal Management * Benefit-Risk ... Experience with DSURs, PSURs/PBRERs, and aggregate safety reports. * Strong knowledge of ICH E2F ...
Washington, DC · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Washington, DC · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Philadelphia, PA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Philadelphia, PA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Boston, MA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Boston, MA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Houston, TX · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Houston, TX · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Miami, FL · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Miami, FL · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Dallas, TX · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Dallas, TX · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
San Jose, CA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
San Jose, CA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Atlanta, GA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Atlanta, GA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Boston, MA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
Boston, MA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
San Francisco, CA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
San Francisco, CA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Chicago, IL · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
Chicago, IL · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Austin, TX · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
Austin, TX · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Seattle, WA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
Quick apply
Seattle, WA · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
$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.
Cities with the most Psur Aggregate Report job openings:
States with the most job openings for Psur Aggregate Report jobs include:
The top searched job categories for Psur Aggregate Report jobs are:

Contractor
Re-posted 21 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.