Pharmacovigilance
North Wales, PA · On-site
Writing SOP's - we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR). Familiarity with any ...
North Wales, PA · On-site
Writing SOP's - we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR). Familiarity with any ...
North Wales, PA · On-site
Writing SOP's - we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR). Familiarity with any ...
WI · On-site
$120 - $160/hr
Own the Quarterly Transaction Report process under the Cornerstone Capacity Agreement, coordinating with the reinsurance broker on aggregate reporting obligations and ensuring fee calculation inputs ...
WI · On-site
$120 - $160/hr
Own the Quarterly Transaction Report process under the Cornerstone Capacity Agreement, coordinating with the reinsurance broker on aggregate reporting obligations and ensuring fee calculation inputs ...
Denver, CO · On-site
$100K - $150K/yr
Brannan Aggregates Reports To: Division Manager Location: Various locations across Colorado, home base Denver, CO Status: Salary Exempt Position Summary: The Aggregate Quality Control Manager ...
Denver, CO · On-site
$100K - $150K/yr
Brannan Aggregates Reports To: Division Manager Location: Various locations across Colorado, home base Denver, CO Status: Salary Exempt Position Summary: The Aggregate Quality Control Manager ...
San Diego, CA · On-site
$180 - $280/hr
Contribute to the planning, preparation, writing, review and QC of aggregate safety reports * Review and contribute to safety sections of key study documents * Ensure ongoing assessment of risk ...
San Diego, CA · On-site
$180 - $280/hr
Contribute to the planning, preparation, writing, review and QC of aggregate safety reports * Review and contribute to safety sections of key study documents * Ensure ongoing assessment of risk ...
These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing ...
These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing ...
... aggregate reporting. The Senior Director of Safety Surveillance serves in a critical enabling and strategic position, ensuring that Revolution Medicines continuously delivers effective scientific ...
... aggregate reporting. The Senior Director of Safety Surveillance serves in a critical enabling and strategic position, ensuring that Revolution Medicines continuously delivers effective scientific ...
Trains and mentors junior physicians assistants, and provides a leadership model in support of the mission for junior physicians assistants in patient care, including aggregate reporting and ...
Trains and mentors junior physicians assistants, and provides a leadership model in support of the mission for junior physicians assistants in patient care, including aggregate reporting and ...
Lead the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. * Work with the EU Qualified Person ...
Lead the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. * Work with the EU Qualified Person ...
These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing ...
These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing ...
Seattle, WA · On-site
$110 - $180/hr
Familiarity with aggregate reporting and signal detection processes * Experience in oncology, cell therapy, or gene therapy preferred #J-18808-Ljbffr
Seattle, WA · On-site
$110 - $180/hr
Familiarity with aggregate reporting and signal detection processes * Experience in oncology, cell therapy, or gene therapy preferred #J-18808-Ljbffr
Lead the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. * Work with the EU Qualified Person ...
Lead the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. * Work with the EU Qualified Person ...
Lead and/or oversee the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. * Work with the EU ...
Lead and/or oversee the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. * Work with the EU ...
These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing ...
These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing ...
Lisle, IL · On-site
$60K - $80K/yr
Quarry & Aggregate Reports To: Quarry & Aggregate Division Ready to ignite your career with a leading dealer of John Deere construction equipment? At West Side Tractor Sales, we believe in fostering ...
Quick apply
Lisle, IL · On-site
$60K - $80K/yr
Quarry & Aggregate Reports To: Quarry & Aggregate Division Ready to ignite your career with a leading dealer of John Deere construction equipment? At West Side Tractor Sales, we believe in fostering ...
The Senior Director will provide broad oversight across case processing, vendor governance, safety systems and processes, aggregate reporting operations, partner interfaces, and operational readiness ...
The Senior Director will provide broad oversight across case processing, vendor governance, safety systems and processes, aggregate reporting operations, partner interfaces, and operational readiness ...
Lisle, IL · On-site
$60K - $80K/yr
Quarry & Aggregate Reports To: Quarry & Aggregate Division Ready to ignite your career with a leading dealer of John Deere construction equipment? At West Side Tractor Sales, we believe in fostering ...
Lisle, IL · On-site
$60K - $80K/yr
Quarry & Aggregate Reports To: Quarry & Aggregate Division Ready to ignite your career with a leading dealer of John Deere construction equipment? At West Side Tractor Sales, we believe in fostering ...
The Senior Director will provide broad oversight across case processing, vendor governance, safety systems and processes, aggregate reporting operations, partner interfaces, and operational readiness ...
The Senior Director will provide broad oversight across case processing, vendor governance, safety systems and processes, aggregate reporting operations, partner interfaces, and operational readiness ...
Emeryville, CA · On-site +1
$170K - $200K/yr
The individual will contribute across case/vendor oversight, compliance, signal management, aggregate reporting, and benefit-risk evaluation. Responsibilities General * Ensure adherence to report ...
Emeryville, CA · On-site +1
$170K - $200K/yr
The individual will contribute across case/vendor oversight, compliance, signal management, aggregate reporting, and benefit-risk evaluation. Responsibilities General * Ensure adherence to report ...
Review of medical and scientific literature to support signal detection and aggregate reporting * Provide safety input to statistical analysis plans, data analysis visualizations, and documents ...
Review of medical and scientific literature to support signal detection and aggregate reporting * Provide safety input to statistical analysis plans, data analysis visualizations, and documents ...
Review of medical and scientific literature to support signal detection and aggregate reporting * Provide safety input to statistical analysis plans, data analysis visualizations, and documents ...
Review of medical and scientific literature to support signal detection and aggregate reporting * Provide safety input to statistical analysis plans, data analysis visualizations, and documents ...
$13.70 - $18.36
11% of jobs
$21.40 is the 25th percentile. Wages below this are outliers.
$18.36 - $23.01
22% of jobs
The median wage is $26.35 / hr.
$23.01 - $27.67
24% of jobs
$27.67 - $32.32
15% of jobs
$33.48 is the 75th percentile. Wages above this are outliers.
$32.32 - $36.98
14% of jobs
$36.98 - $41.63
4% of jobs
$41.63 - $46.28
3% of jobs
$46.28 - $50.94
2% of jobs
$50.94 - $55.59
4% of jobs
$55.59 - $60.25
1% of jobs
$60.25 - $64.90
0% of jobs
$13
$31
$64
An Aggregate Reporting job involves the collection, analysis, and submission of safety data for pharmaceutical products. Professionals in this role ensure regulatory compliance by preparing periodic safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs). They collaborate with pharmacovigilance teams to assess drug safety trends and potential risks. Strong knowledge of global regulatory requirements, data analysis, and medical writing is essential for this role.
Professionals in Aggregate Reporting are responsible for collecting, analyzing, and compiling safety data from various sources to prepare regulatory reports such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Annual Safety Reports (ASRs). On a daily basis, you may coordinate with cross-functional teams in pharmacovigilance, clinical, and regulatory affairs to ensure accuracy and compliance with global reporting timelines. You may also review case data, manage data entry and quality checks, and respond to regulatory queries. This role often involves juggling multiple projects simultaneously, making time management and organizational skills highly important for success.
To thrive in Aggregate Reporting, strong analytical skills, attention to detail, and experience with data management in regulated environments—often supported by a background in life sciences, statistics, or pharmacy—are essential. Familiarity with pharmacovigilance databases, regulatory reporting tools (such as ARISg or Argus Safety), and industry certifications like RQA or safety/pharmacovigilance credentials are highly valued. Strong communication, organization, and problem-solving skills help professionals excel when gathering data from multiple sources and working cross-functionally. These capabilities ensure regulatory compliance and the accurate, timely submission of aggregate safety reports critical to patient safety and company operations.

Education: Bachelor's degree or Master's degree or Advance level degree in a life science/healthcare/pharmaceutical related field.
Required: Candidate is required to have at least 2 years of pharmacovigilance safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory preferred. Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible in order to meet daily competing priorities of the business. Ability to independently contribute effectively to group projects, handle individual tasks, and take initiative when necessary. Veeva Vault experience preferred.
Software: MS office suite. Veeva Vault is preferred.
Personality: Detail Oriented. Able to work independently. Team Player. Excellent written and verbal communication skills.
Note: 1 year assignment. Hybrid assignment (2 days/week onsite). Work Location: Upper Gwynedd, PA.
Documentation and training role. Writing SOP's - we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR). Familiarity with any Learning management system. Experience with My learning system is a plus. Need someone who can deliver and create trainings. Experience with safety database. Experience with VEEVA Vault is a plus.
Responsibilities:
We are looking for (2) Contractors to support PV Operations and Global Process Enablement in Documentation and Training and PV Quality and Compliance with responsibilities to include:
Comments/Special Instructions: Documentation and training role. Writing SOP's-we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus of Individual Case Safety Report (ICSR). Familiarity with LMS-My learning is a plus. Someone who can deliver and create trainings. Experience with safety database. Experience with VEEVA Vault is a plus.
If interested, kindly send updated copy of resume with following answers:
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11 - 50 Employees
Sugar Land, TX, US