Basic knowledge of MedDRA coding. * Experience in ICSR case-processing and reporting. * Experience working in and with safety databases. * Direct experience managing relationships with service ...
Basic knowledge of MedDRA coding. * Experience in ICSR case-processing and reporting. * Experience working in and with safety databases. * Direct experience managing relationships with service ...
Basic knowledge of MedDRA coding. * Experience in ICSR case-processing and reporting. * Experience working in and with safety databases.
Basic knowledge of MedDRA coding. * Experience in ICSR case-processing and reporting. * Experience working in and with safety databases.
Director, Safety Scientist
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Director, Safety Scientist
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Experience with MedDRA coding, Points to Consider, AoSE, and SMQs * Excellent verbal, written and presentation skills
Experience with MedDRA coding, Points to Consider, AoSE, and SMQs * Excellent verbal, written and presentation skills
Director, Safety Scientist
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Director, Safety Scientist
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding * Experience with authoring or contributing to aggregate safety reports, signal ...
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding * Experience with authoring or contributing to aggregate safety reports, signal ...
Ensure highquality MedDRA coding, oncologyappropriate event characterization, and robust safety narratives.Lead safety review meetings and oversee followup of serious and immunemediated adverse ...
Ensure highquality MedDRA coding, oncologyappropriate event characterization, and robust safety narratives.Lead safety review meetings and oversee followup of serious and immunemediated adverse ...
Director, Safety Scientist
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Director, Safety Scientist
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Director, Safety Scientist (Boston)
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Director, Safety Scientist (Boston)
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)
Boston, MA · On-site
$200K - $250K/yr
Ensure high-quality MedDRA coding, oncology-appropriate event characterization, and robust safety narratives.Lead safety review meetings and oversee follow-up of serious and immune-mediated adverse ...
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)
Boston, MA · On-site
$200K - $250K/yr
Ensure high-quality MedDRA coding, oncology-appropriate event characterization, and robust safety narratives.Lead safety review meetings and oversee follow-up of serious and immune-mediated adverse ...
Director, Safety Scientist
$175K - $263K/yr
Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and ...
Director, Safety Scientist
$175K - $263K/yr
Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and ...
VAERS Clinician
Haines City, FL · Remote
$60.58 - $64.90/hr
MedDRA coding experience required. * Have a clinical background (e.g. physician, physician assistant, nurse practitioner, register nurse); contract employee does not need to be a licensed MD. * Have ...
VAERS Clinician
Haines City, FL · Remote
$60.58 - $64.90/hr
MedDRA coding experience required. * Have a clinical background (e.g. physician, physician assistant, nurse practitioner, register nurse); contract employee does not need to be a licensed MD. * Have ...
Working knowledge of MedDRA coding and case series retrieval strategies. Experience using a large-scale electronic data storage and retrieval system. Requires strong attention to detail in composing ...
Working knowledge of MedDRA coding and case series retrieval strategies. Experience using a large-scale electronic data storage and retrieval system. Requires strong attention to detail in composing ...
Sr. Scientist, Drug Safety (Pharmacovigilance)
$145K - $190K/yr
Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred. * Experience supporting clinical safety case processing ...
Sr. Scientist, Drug Safety (Pharmacovigilance)
$145K - $190K/yr
Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred. * Experience supporting clinical safety case processing ...
Director, Safety Scientist (Boston)
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
New
Director, Safety Scientist (Boston)
Boston, MA · On-site
$175K - $263K/yr
Experience in MedDRA coding and search strategies * Excellent, independent judgment based on knowledge and expertise * Strong personal time-management and project-management skills * Mastery of ...
New
Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented * Working knowledge of global ...
Quick apply
Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented * Working knowledge of global ...
Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented * Working knowledge of global ...
Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented * Working knowledge of global ...
Argus), regulatory regulations, and MedDRA coding. * Excellent interpersonal, organizational, and communication skills. * Strong project management and problem-solving abilities. * Attention to ...
Argus), regulatory regulations, and MedDRA coding. * Excellent interpersonal, organizational, and communication skills. * Strong project management and problem-solving abilities. * Attention to ...
Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented * Working knowledge of global ...
Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented * Working knowledge of global ...
Senior Manager, Drug Safety
Rockville, MD · On-site
Ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications. * Support the clinical research team in the preparation/review of safety ...
Senior Manager, Drug Safety
Rockville, MD · On-site
Ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications. * Support the clinical research team in the preparation/review of safety ...
Meddra Coder information
See salary details
$15.87 - $17.55
6% of jobs
$18.74 is the 25th percentile. Wages below this are outliers.
$17.55 - $19.23
26% of jobs
The median wage is $20.19 / hr.
$19.23 - $20.91
31% of jobs
$20.91 - $22.60
7% of jobs
$23.31 is the 75th percentile. Wages above this are outliers.
$22.60 - $24.28
11% of jobs
$24.28 - $25.96
6% of jobs
$25.96 - $27.64
5% of jobs
$27.64 - $29.33
3% of jobs
$29.33 - $31.01
2% of jobs
$31.01 - $32.69
1% of jobs
$32.69 - $34.38
1% of jobs
$15
$22
$34
How much do meddra coder jobs pay per hour?
What are the key skills and qualifications needed to thrive as a MedDRA Coder, and why are they important?
What are some common challenges faced by MedDRA Coders when standardizing medical terminology in clinical trial data?
What is a MedDRA Coder?
What is the difference between Meddra Coder vs Medical Coder?
| Aspect | Meddra Coder | Medical Coder |
|---|---|---|
| Credentials | Certification in MedDRA coding, often through specialized training | Certification like CPC or CCS, with focus on ICD, CPT, or HCPCS coding |
| Work Environment | Pharmaceutical, clinical research, or healthcare settings focusing on adverse event reporting | Hospitals, clinics, insurance companies, and healthcare providers |
| Industry Usage | Used primarily in drug safety and pharmacovigilance | Used broadly across healthcare for billing, documentation, and coding |
While both Meddra Coder and Medical Coder work with medical coding, Meddra Coder specializes in coding adverse events and drug safety data using MedDRA terminology, whereas Medical Coders handle billing and documentation coding across various medical specialties. The roles differ mainly in their focus and industry applications.
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Other
Posted 23 days ago
Job description
The Role:
Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director, PV Operations will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be responsible for PV operations' role in Phase 1, 2, & 3 clinical studies, inclusive of inspection readiness, reconciliation, SMP maintenance, and site and regulatory authority reporting oversight. They will work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.
Responsibilities:
- Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
- Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
- Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
- Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
- Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
- Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
- Serve as PV operations SME on safety reporting processes according to study protocol.
- Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
- Serve as resource and contact for other functions within the company for pharmacovigilance
- operational activities.
- Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation
- Â
- Responsible for the development of safety management plans for assigned programs, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered to
Competencies Include:
- Excellent written and verbal communication skills.
- Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
- Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
- Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
- Demonstrated project management and prioritization capabilities.
Qualifications:
- Bachelor's degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
- 8-10 years of progressive drug safety experience in a biotech/pharma company.
- Clinical Development experience.
- Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
- Ability to interpret and follow regulatory guidelines.
- Proven knowledge of Good Documentation Practices and cGXPs.
- Basic knowledge of MedDRA coding.
- Experience in ICSR case-processing and reporting.
- Experience working in and with safety databases.
- Direct experience managing relationships with service providers or external business partners
About Nuvalent
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Cambridge, MA, US
Year founded
2017