... aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. * Prepare and review Medical Monitoring Plans and Safety Management Plans, and ...
... aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. * Prepare and review Medical Monitoring Plans and Safety Management Plans, and ...
Senior Medical Officer
Rockville, MD · On-site
... aggregate reports as applicable. * Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding. * Reviews the FDA MedWatch Alerts, safety communications and or ...
Senior Medical Officer
Rockville, MD · On-site
... aggregate reports as applicable. * Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding. * Reviews the FDA MedWatch Alerts, safety communications and or ...
Plant Maintenance Technician
Manassas, VA · On-site
$22 - $29.75/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Plant Maintenance Technician
Manassas, VA · On-site
$22 - $29.75/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Plant Maintenance Technician
Manassas, VA · On-site
$20.50 - $28/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Plant Maintenance Technician
Manassas, VA · On-site
$20.50 - $28/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Radiant Logic Engineer
Mclean, VA · On-site
Tuning aggregation tasks * Supporting application connectivity and IAM reporting issues * Software developer mindset * Database knowledge * Performance monitoring experience * B.S. degree in Computer ...
Radiant Logic Engineer
Mclean, VA · On-site
Tuning aggregation tasks * Supporting application connectivity and IAM reporting issues * Software developer mindset * Database knowledge * Performance monitoring experience * B.S. degree in Computer ...
Senior Medical Officer
Rockville, MD · Remote
... aggregate reports as applicable. * Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding. * Reviews the FDA MedWatch Alerts, safety communications and or ...
Senior Medical Officer
Rockville, MD · Remote
... aggregate reports as applicable. * Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding. * Reviews the FDA MedWatch Alerts, safety communications and or ...
Senior Medical Officer
Rockville, MD · On-site
... aggregate reports as applicable. * Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding. * Reviews the FDA MedWatch Alerts, safety communications and or ...
Senior Medical Officer
Rockville, MD · On-site
... aggregate reports as applicable. * Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding. * Reviews the FDA MedWatch Alerts, safety communications and or ...
Sr. Paralegal
Washington, DC · On-site
$47K - $61K/yr
Aggregates reports from other teams and prepares reports for Supervisors as needed. * Assists Supervisors in claim assignments as needed. * Assists Supervisors in queue management of claim reviewer ...
Sr. Paralegal
Washington, DC · On-site
$47K - $61K/yr
Aggregates reports from other teams and prepares reports for Supervisors as needed. * Assists Supervisors in claim assignments as needed. * Assists Supervisors in queue management of claim reviewer ...
Plant Maintenance Technician (Second Shift)
Lorton, VA · On-site
$22.25 - $30/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Plant Maintenance Technician (Second Shift)
Lorton, VA · On-site
$22.25 - $30/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Healthcare Account Analyst
Bethesda, MD · On-site
... aggregator reports. • Other duties as assigned or requested. Required Education and Experience: EDUCATION Required • High School Diploma/GED Preferred • Bachelor's degree in Business ...
Healthcare Account Analyst
Bethesda, MD · On-site
... aggregator reports. • Other duties as assigned or requested. Required Education and Experience: EDUCATION Required • High School Diploma/GED Preferred • Bachelor's degree in Business ...
Lead the design and delivery of Java-based microservices supporting analytics, search, aggregation, and reporting workflows * Own analytics architecture across three primary query/analysis patterns ...
Lead the design and delivery of Java-based microservices supporting analytics, search, aggregation, and reporting workflows * Own analytics architecture across three primary query/analysis patterns ...
Senior Software Engineer (Analytics Services) with Security Clearance
Reston, VA · On-site
$127K - $168K/yr
Lead the design and delivery of Java-based microservices supporting analytics, search, aggregation, and reporting workflows * Own analytics architecture across three primary query/analysis patterns ...
Senior Software Engineer (Analytics Services) with Security Clearance
Reston, VA · On-site
$127K - $168K/yr
Lead the design and delivery of Java-based microservices supporting analytics, search, aggregation, and reporting workflows * Own analytics architecture across three primary query/analysis patterns ...
Lead the design and delivery of Java-based microservices supporting analytics, search, aggregation, and reporting workflows * Own analytics architecture across three primary query/analysis patterns ...
Lead the design and delivery of Java-based microservices supporting analytics, search, aggregation, and reporting workflows * Own analytics architecture across three primary query/analysis patterns ...
Plant Maintenance Technician (Second Shift)
Lorton, VA · On-site
$22.25 - $30/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
Plant Maintenance Technician (Second Shift)
Lorton, VA · On-site
$22.25 - $30/hr
... aggregate crushing, washing, and screening areas to identify problems and ensure safety and materials compliance. Document and Record Information. Enter and maintain service and lubrication reports ...
... monthly aggregator reports. · Other duties as assigned or requested. Required Education and Experience: EDUCATION Required * High School Diploma/GED Preferred * Bachelor's degree in Business ...
New
Quick apply
... monthly aggregator reports. · Other duties as assigned or requested. Required Education and Experience: EDUCATION Required * High School Diploma/GED Preferred * Bachelor's degree in Business ...
New
... reporting and data aggregation Proven ability to aggregate and normalize results from multiple microservices and multiple pipelines. Experience producing actionable automated reports (trend analysis ...
... reporting and data aggregation Proven ability to aggregate and normalize results from multiple microservices and multiple pipelines. Experience producing actionable automated reports (trend analysis ...
Reports To: Sr. Director, Performance Marketing About the Role Within Marketing at GEICO - a team in the middle of a significant transformation - affiliate and aggregator channels are a major and ...
Reports To: Sr. Director, Performance Marketing About the Role Within Marketing at GEICO - a team in the middle of a significant transformation - affiliate and aggregator channels are a major and ...
Conduct medical review of adverse events and safety signals Perform benefit-risk assessments Support regulatory safety reporting and submissions Contribute to safety management plans and aggregate ...
Conduct medical review of adverse events and safety signals Perform benefit-risk assessments Support regulatory safety reporting and submissions Contribute to safety management plans and aggregate ...
Support regulatory safety reporting and submissions * Contribute to safety management plans and aggregate safety reports * Provide clinical input into protocols and regulatory documents Minimum ...
Quick apply
Support regulatory safety reporting and submissions * Contribute to safety management plans and aggregate safety reports * Provide clinical input into protocols and regulatory documents Minimum ...
... aggregate safety reports • Provide clinical input into protocols and regulatory documents Minimum Qualifications: • MD or DO required • 5+ years of pharmacovigilance or clinical research ...
... aggregate safety reports • Provide clinical input into protocols and regulatory documents Minimum Qualifications: • MD or DO required • 5+ years of pharmacovigilance or clinical research ...
Aggregate Reporting information
See Washington salary details
$15.52 - $20.79
11% of jobs
$24.24 is the 25th percentile. Wages below this are outliers.
$20.79 - $26.06
22% of jobs
The median wage is $29.84 / hr.
$26.06 - $31.33
24% of jobs
$31.33 - $36.61
15% of jobs
$37.92 is the 75th percentile. Wages above this are outliers.
$36.61 - $41.88
14% of jobs
$41.88 - $47.15
4% of jobs
$47.15 - $52.42
3% of jobs
$52.42 - $57.69
2% of jobs
$57.69 - $62.97
4% of jobs
$62.97 - $68.24
1% of jobs
$68.24 - $73.51
0% of jobs
$15
$35
$73
How much do aggregate reporting jobs pay per hour?
What is an aggregate reporting?
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.
What are the typical daily responsibilities of someone working in aggregate reporting?
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.
What are the key skills and qualifications needed to thrive in aggregate reporting, and why are they important?
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.

Senior Manager, Drug Safety and Medical Monitoring
Rockville, MD • On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 18 days ago
Job description
Job Summary:
The Senior Manager of Drug Safety and Medical Monitor will provide medical monitoring support to the drug safety and medical monitoring team. They will conduct medical reviews of clinical research data, safety alerts and notification, SAE narratives, and pertinent source documents. Responsibilities also include reviewing and processing documents relevant to medical monitoring activities and providing medical input to internal teams such as Clinical Development, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Medical Writing.
Essential Duties & Responsibilities:
- Conduct medical reviews of clinical trial safety data and provide input to internal teams (Clinical Development, Drug Safety, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, and Medical Writing).
- Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
- Conduct medical reviews and perform user acceptance testing of electronic case report forms (eCRF) to ensure medical consistency of clinical and safety data collection.
- Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File, shared drive, etc.) for all applicable clinical trials.
- Conduct medical reviews of Tables/Listings/Figures (TLF), clinical study reports (CSR), and provide input to Clinical Development, Medical Writing, Data Management and Clinical Operations Teams.
- Review, categorize, and maintain the Medical Monitoring Outlook folder.
- Review and file safety alerts and notifications and communicate notable values to the Medical Monitoring Lead.
- Track and ensure timely review of the protocol deviations for all applicable clinical trials.
- Review coding to ensure accuracy of MedDRA coding for adverse event terms, medical history, and procedures, and WHO Drug coding for concomitant medications.
- Conduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead.
- Prepare and review Medical Monitoring Plans and Safety Management Plans, and participate in Site Initiation Visits.
- Provide medical input and review of annual reports, PADERs, PSURs, DSURs, other benefit-risk assessment reports, updates to package inserts/labels, and Summaries of Product Characteristics (SmPCs).
- Participate in and present at Clinical Development training and meetings; prepare meeting agendas and minutes, as applicable.
- Draft and review Standard Operating Procedures (SOPs).
- Review Statements of Work and vendor budgets for all applicable medical monitoring tasks and escalate issues to relevant team members.
- Support the Drug Safety and Medical Monitoring team in the preparation and review of safety reports and data, e.g., cumulative SAE reports, safety database reports, MedWatch Reports, and other reports, as deemed necessary.
- Maintain up-to-date knowledge of all applicable drug safety guidelines and regulations (FDA, ICH, MHRA, EMA) and apply them to medical monitoring tasks relevant to disease areas and therapeutic areas for both marketed drugs and drugs in development.
- Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures
- Perform other duties as assigned.
Supervisory Responsibilities:
- N/A.
Knowledge & Other Qualifications:
- Degree in a medical field, MD, DO, MBBS, Nurse Practitioner, or equivalent is required with a minimum of three years of relevant experience.
- Knowledge of medical and therapeutic terminology, including WHO Drug and MedDRA dictionaries.
- Experience in medical monitoring and medical review.
- Experience in authoring Standard Operating Procedures.
- Experience with clinical and safety databases, and Veeva Systems.
- Working knowledge of ICH guidelines and other global safety regulations.
- Demonstrated working knowledge of FDA regulations relevant to patient safety and adverse event reporting, including periodic safety reporting.
- Working knowledge of principles and concepts associated with patient safety case-handling processes, including regulatory reporting requirements, policies, processes, and procedures.
Other Characteristics:
- Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
- Ability of having an innovative and dynamic approach to work.
- A self-starter able to work independently but comfortable working in a team environment.
- Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
- Capable of performing other duties as assigned by Management.
- Authorized to legally work in the United States without visa sponsorship.
Physical Requirements/Work Environment/Travel Requirements:
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
- The worker is required to have close visual acuity to perform activities such as preparing and analyzing data and figures, transcribing, viewing a computer screen, iPad, or other electronic device, and extensive reading. Strong attention to detail is essential to ensure accuracy and consistency in all tasks involving data review and documentation.
- The worker is not substantially exposed to adverse environmental conditions.
Compensation:
At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $131,000 to $155,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
About Supernus Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Rockville, MD, US
Year founded
2005