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 ...
$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 ...
$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 ...
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 ...
Oversee appropriate MedDRA coding of postmarketing ICSRs and lead the development of product-specific coding guidelines Signal Detection - Safety Governance * Lead signal detection and management ...
Oversee appropriate MedDRA coding of postmarketing ICSRs and lead the development of product-specific coding guidelines Signal Detection - Safety Governance * Lead signal detection and management ...
Familiarity with MedDRA coding and case processing workflows * Knowledge of applicable standards, including ISO 13485 and ISO 14971 * Preferred * Advanced degree (PharmD, MD, MPH, MSc) * Experience ...
Familiarity with MedDRA coding and case processing workflows * Knowledge of applicable standards, including ISO 13485 and ISO 14971 * Preferred * Advanced degree (PharmD, MD, MPH, MSc) * Experience ...
Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value ...
Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value ...
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 ...
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 is required. * In-depth understanding of U.S. Regulations pertaining to adverse event reporting. * Skills & Attributes: * Excellent communication (verbal and written) and ...
Proficiency in MedDRA coding is required. * In-depth understanding of U.S. Regulations pertaining to adverse event reporting. * Skills & Attributes: * Excellent communication (verbal and written) and ...
Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value ...
Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value ...
Argus), regulatory regulations, and MedDRA coding. * Excellent interpersonal, organizational, and communication skills. * Strong project management and problem-solving abilities. * Attention to ...
Quick apply
Argus), regulatory regulations, and MedDRA coding. * Excellent interpersonal, organizational, and communication skills. * Strong project management and problem-solving abilities. * Attention to ...
Emeryville, CA · On-site
$170K - $200K/yr
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required * Understanding of how AI can be applied in Pharmacovigilance is a plus ...
Emeryville, CA · On-site
$170K - $200K/yr
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required * Understanding of how AI can be applied in Pharmacovigilance is a plus ...
Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value ...
Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value ...
Familiarity with MedDRA coding and case processing workflows * Knowledge of applicable standards, including ISO 13485 and ISO 14971 * Preferred * Advanced degree (PharmD, MD, MPH, MSc) * Experience ...
Quick apply
Familiarity with MedDRA coding and case processing workflows * Knowledge of applicable standards, including ISO 13485 and ISO 14971 * Preferred * Advanced degree (PharmD, MD, MPH, MSc) * Experience ...
Familiarity with MedDRA coding and case processing workflows * Knowledge of applicable standards, including ISO 13485 and ISO 14971 * Preferred * Advanced degree (PharmD, MD, MPH, MSc) * Experience ...
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 ...
Emeryville, CA · On-site +1
$170K - $200K/yr
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required * Understanding of how AI can be applied in Pharmacovigilance is a plus ...
Emeryville, CA · On-site +1
$170K - $200K/yr
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required * Understanding of how AI can be applied in Pharmacovigilance is a plus ...
Emeryville, CA · On-site +1
$170K - $200K/yr
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required * Understanding of how AI can be applied in Pharmacovigilance is a plus ...
Quick apply
Emeryville, CA · On-site +1
$170K - $200K/yr
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required * Understanding of how AI can be applied in Pharmacovigilance is a plus ...
Ensure integrity, accuracy, and completeness of the safety database; oversee MedDRA coding quality and consistency. Signal Detection, Risk Management, and DSMB Support * Lead routine and ad hoc ...
Ensure integrity, accuracy, and completeness of the safety database; oversee MedDRA coding quality and consistency. Signal Detection, Risk Management, and DSMB Support * Lead routine and ad hoc ...
Ensure integrity, accuracy, and completeness of the safety database; oversee MedDRA coding quality and consistency. Signal Detection, Risk Management, and DSMB Support * Lead routine and ad hoc ...
Ensure integrity, accuracy, and completeness of the safety database; oversee MedDRA coding quality and consistency. Signal Detection, Risk Management, and DSMB Support * Lead routine and ad hoc ...
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 ...
$9.13 - $11.01
21% of jobs
$11.41 is the 25th percentile. Wages below this are outliers.
$11.01 - $12.89
20% of jobs
$12.89 - $14.77
8% of jobs
The median wage is $15.15 / hr.
$14.77 - $16.65
5% of jobs
$16.65 - $18.53
0% of jobs
$18.53 - $20.41
0% of jobs
$20.41 - $22.29
0% of jobs
$22.29 - $24.17
9% of jobs
$26.05 is the 75th percentile. Wages above this are outliers.
$24.17 - $26.05
11% of jobs
$26.05 - $27.93
13% of jobs
$27.93 - $29.81
13% of jobs
$9
$19
$29
A MedDRA Coding job involves assigning standardized Medical Dictionary for Regulatory Activities (MedDRA) terms to adverse events, medical conditions, and drug-related data in clinical trials and pharmacovigilance. Coders ensure consistency and accuracy in medical terminology to support regulatory reporting and safety analysis. This role requires knowledge of MedDRA hierarchy, coding guidelines, and industry regulations. Professionals often work in pharmaceutical companies, contract research organizations (CROs), or regulatory agencies. Strong attention to detail and familiarity with medical terminology are essential skills for this job.
To excel in MedDRA Coding, a strong understanding of medical terminology, clinical research processes, and pharmacovigilance concepts—often supported by a life sciences degree or healthcare background—is essential. Familiarity with the MedDRA (Medical Dictionary for Regulatory Activities) system, coding software, and relevant regulatory guidelines, along with certifications in drug safety or medical coding, is highly valued. Attention to detail, analytical thinking, and effective communication are standout soft skills for this position. These competencies are crucial to ensure accurate and consistent coding of medical terms, enabling high-quality safety data analysis and regulatory compliance.
A MedDRA Coding specialist is primarily responsible for translating medical information from clinical trial reports, adverse event forms, or safety databases into standardized MedDRA terms. This ensures accurate data capture, analysis, and reporting for regulatory submissions and ongoing safety monitoring. Specialists often collaborate with drug safety teams, medical writers, and data managers to resolve coding discrepancies and maintain consistency in terminology. In addition, the role may involve participating in cross-functional meetings and providing coding support during audits or inspections. Working efficiently and maintaining up-to-date knowledge of MedDRA updates are also key aspects of the job.

$175K - $263K/yr
Full-time
Medical, Dental, Vision, Retirement, PTO
Posted yesterday
Lead risk management evaluation and resolution for assigned products and projects.
Organize, train, and support junior safety scientists and fellows across multiple product portfolios and indications.
Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework.
You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:
Proven skill set for strategic leadership in a cross functional matrix
Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
Co-lead activities related to new drug applications and other regulatory filings
Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation
Leading activities to identify and address process gaps
Responsible for vendor management and training including budgets
Responsible for overall project distribution across therapeutic area
As needed represent GPS in global program teams and associated cross functional teams and/or projects
Proactively provide guidance and educational training to GPS therapeutic teams
Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians.
Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
You will have:
Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry
Knowledge and understanding of US and EU safety regulations pre- and post- marketing
Experience with Risk Management and Minimization programs
Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans
Experience with clinical development including risk/benefit analysis and safety assessment
Strong clinical, analytical, problem solving and scientific writing and communication skills
We would prefer you have:
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 project-management skills
Mastery of Microsoft Word, PowerPoint and Excel
The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
15-Jun-2026Closing Date
30-Jun-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Medical equipment and supplies manufacturing
1,001 - 5,000 Employees
Boston, MA, US
1992