Pharmacovigilance. Safety physicians services. Patient Safety.
Advancing Safer Therapies. Improving Lives.
GeneMaris Health provides end-to-end pharmacovigilance and drug safety solutions for pharmaceutical, biotech, and clinical research organizations. We transform safety data into actionable insights that protect patients and strengthen your products.
Our Core Services
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Case Processing
& Medical ReviewTimely and accurate processing, evaluation, and narrative writing of safety reports.
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Signal Detection
& ManagementProactive signal detection and evaluation using advanced tools and scientific expertise.
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Risk Management
& Safety StrategyDeveloping and executing risk management plans to optimize benefit–risk profiles.
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Regulatory Reporting
& SubmissionsPreparation of PSUR, PBRER, DSUR, PADER and other aggregate safety reports for global submissions.
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Literature Surveillance
& IntelligenceComprehensive monitoring of scientific literature for emerging safety information.
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Quality & Compliance
Ensuring data quality, compliance, and readiness through audits, QC and reconciliation activities.
Therapeutic Expertise
Our safety physicians and scientists bring hands-on experience across complex therapeutic areas, so your products are reviewed by people who understand the disease, the patients, and the risks.
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Oncology
Safety support across solid tumors and hematologic malignancies, including immuno-oncology and novel modalities with complex toxicity profiles.
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Hematology & Immunology
Monitoring for biologics and small molecules in autoimmune and inflammatory disease, with close attention to infection risk and long-term exposure.
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Rare Diseases
Pharmacovigilance for orphan drugs and small patient populations, where every case matters and post-marketing commitments are demanding.
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Neuroscience
Safety expertise in CNS therapies, from psychiatric indications to neurodegenerative disease, including abuse-potential and suicidality assessments.
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Cardiology
Signal evaluation for therapies used by large, long-term patient populations, including cardiac, hepatic, and renal safety monitoring.
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Working in another area?
We support programs across many indications. Tell us about yours and we'll connect you with the right expert.
Talk to our team
How We Work
A clear, structured path from first conversation to fully managed safety operations, built to keep you compliant at every stage.
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Discovery & Scoping
We review your products, safety obligations, and current processes to define the right scope and service model.
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Transition & Onboarding
A structured plan moves case intake, data, and SOPs to our team, designed to avoid gaps in compliance or reporting timelines.
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Safety Operations
Our team runs day-to-day case processing, signal management, and reporting, with clear KPIs and regular governance reviews.
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Continuous Improvement
We track quality metrics, stay ahead of regulatory change, and refine processes as your portfolio grows.
About GeneMaris Health
GeneMaris Health is a pharmacovigilance and drug safety services company dedicated to supporting innovation in oncology, immunology, and other therapeutic areas.
Our team of safety professionals, physicians, and scientists bring deep expertise and a commitment to excellence in patient safety and regulatory compliance.
Learn More About Us-
5+Safety Professionals
& Medical Experts -
100+Global Clients &
Clinical Programs -
3Countries Supported
Worldwide
Our Mission: Safeguarding patients. Strengthening therapies. Advancing global health.
Get in touch
Let's talk about your safety program
Whether you need case processing support, an aggregate report, or a full pharmacovigilance partner, tell us what you're working on and our team will get back to you.
- Email GMHealth@genemaris.com
- Phone +1 (443) 320-5293
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Location
Baltimore,
Maryland
End-to-end handling of individual case safety reports (ICSRs) from clinical trials, spontaneous reports, literature, and patient support programs, processed accurately and submitted on time.
What's included
- Case intake, triage, and duplicate checks
- Data entry with MedDRA and WHO Drug coding
- Medical review, causality, and expectedness assessment
- Narrative writing and follow-up management
- End-to-End Safety Database request management
A structured, documented process for finding, validating, and assessing new safety signals across your product's entire lifecycle.
What's included
- Qualitative and quantitative signal detection, including disproportionality analysis
- Data mining of your safety database and public sources such as FAERS
- Signal validation, prioritization, and assessment
- Signal tracking and documentation for audit readiness
- Investigations into emerging safety signals on onging treatments
- Support for safety management teams and governance meetings
Strategic safety planning that keeps the benefit–risk balance of your products clear to regulators, prescribers, and patients.
What's included
- EU Risk Management Plan (RMP) and US REMS development and updates
- Additional risk minimisation measures and effectiveness evaluation
- Benefit–risk assessments and product safety strategy
- Reference Safety Information (RSI) and core safety information support
- Safety input for regulatory meetings and health authority queries
Authoring and coordination of periodic aggregate safety reports that meet global regulatory requirements and deadlines.
What's included
- PSUR / PBRER authoring to ICH E2C(R2)
- DSUR authoring to ICH E2F
- PADERs for the US FDA
- Addendum to Clinical Overview and bridging reports
- Submission calendar tracking, data lock planning, and QC
Systematic screening of global and local scientific literature to capture reportable cases and emerging safety information.
What's included
- Weekly global literature searches in databases such as Embase and MEDLINE
- Local and regional journal monitoring
- Identification of reportable cases and safety-relevant findings
- EMA Medical Literature Monitoring (MLM) reconciliation
- Search strategy design with a documented audit trail
Keeping your pharmacovigilance system inspection-ready through robust quality management, oversight, and continuous monitoring.
What's included
- PV System Master File (PSMF) maintenance
- Compliance KPIs and submission timeliness tracking
- Quality control of cases and aggregate reports
- Safety data reconciliation with clinical, quality, and medical information teams
- Audit and inspection readiness support, including CAPA management