Top 141 global pharmacovigilance Jobs in remote

Principal Statistician, Biostatistics
Jazz Pharmaceuticals —Palo Alto, CA
- $132,000 - $198,000 a year
- Remote
- Analysis skills
- Doctor of Philosophy
- Senior level
- Health insurance
- Dental insurance
Assoc. Medical Director (Rheumatology, Remote)
Lenox Executive Search —Remote
- $150 - $170 an hour
- Contract
- Remote
- Medicine
- Doctoral degree
- Patient monitoring
Quick Apply
Associate Director, Clinical Quality Assurance
Vera Therapeutics, Inc. —Remote
- $140,000 - $214,000 a year
- Remote
- 8 years
- Bachelor's degree
- Continuous improvement
TMF Manager, Clinical QA
Vera Therapeutics, Inc. —Remote
- $104,000 - $159,000 a year
- Remote
- 8 years
- Bachelor's degree
- Senior level
Global Quality Assurance Auditor, Pharmacovigilance
GE HEALTHCARE —Remote
- $106,400 - $159,600 a year
- 6 years
- Pass drug screening
- Data analysis skills
- Health insurance
- Dental insurance
Drug Safety Pharmaceutical Consultants
Lachman Consultant Services —Remote
- Online Application
- Bachelor of Science
- Data analysis skills
- Bachelor's degree
Consultant - Pharmacovigilance/Safety Systems Implementation (Remote)
Veeva Systems —Remote
- $80,000 - $200,000 a year
- Full-time
- Remote
- Computer science
- Computer Science
- Up to 50% travel
- Paid holidays
- Health insurance
Medical Science Liaison
Corza Medical —Remote
- $150,000 - $175,000 a year
- Full-time
- Remote
- 5 years
- Surgery
- Bachelor's degree
- Continuing education credits
- Health insurance
Senior Director, Clinical Operations
Syncromune —Remote
- $250,000 - $275,000 a year
- Full-time
- Background check
- 11+ years
- Office
Quick Apply
Senior Medical Writer
Argenx —Remote
- $128,000 - $176,000 a year
- Full-time
- Remote
- English
- Microsoft Office
- 3 years
- Health insurance
- Retirement plan
Senior Consultant - Pharmacovigilance/Safety Systems Implementation (Remote)
Veeva Systems —Remote
- $80,000 - $200,000 a year
- Full-time
- Remote
- Oracle
- Computer Science
- Up to 50% travel
- Paid holidays
- Health insurance
Business Consultant - Life Sciences R&D
Veeva Systems —Remote
- $70,000 - $140,000 a year
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
- Paid holidays
- Health insurance
Manager, PVRM
Sumitomo Pharma America, Inc. —Remote
- $127,900 - $159,900 a year
- Full-time
- Pass drug screening
- Office
- Master's degree
- Paid holidays
- Health insurance
Associate Director, Clinical Quality Assurance Auditor
Cytokinetics —Remote
- $195,300 - $227,850 a year
- Full-time
- Remote
- Bachelor's degree
- Travel
- Senior level
Clinician, Companion Animal Clinical Development
Zoetis —Remote
- $105,000 - $145,000 a year
- Online Application
- 3 years
- Doctor of Philosophy
- US work authorization
- Profit sharing
- Health insurance
Consultant - R&D Advisory - US
サイネオス・ヘルス —Remote
- $122,000 - $135,000 a year
- Remote
- Master's degree
- Bachelor's degree
- Experience equivalent to degree accepted
- Health insurance
- Dental insurance
Senior Consultant - Regulatory Operations Software Implementation (Remote)
Veeva Systems —Remote
- $80,000 - $200,000 a year
- Full-time
- Remote
- Oracle
- Salesforce
- 8 years
- Paid holidays
- Health insurance
Senior Director, Risk Management, DSPV
Vera Therapeutics, Inc. —Remote
- $220,000 - $305,000 a year
- Medicine
- Computer literacy
- 11+ years
Senior Manager, Pharmacovigilance Operations
Agenus Inc —Remote
- Full-time
- Quality control
- Senior level
- Employee stock purchase plan
- Health insurance
Medical Safety Lead
Argenx —Remote
- $292,000 - $401,500 a year
- Full-time
- Remote
- Medicine
- Management
- English
- Health insurance
- Retirement plan

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global pharmacovigilance jobs near remote

Principal Statistician, Biostatistics

Jazz Pharmaceuticals -
Palo Alto, CA

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Job Details

$132,000 - $198,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Hypothesis testing
Biostatistics-based research
SAS
Design of experiments
R
Drug regulation
SAS language
Research project design
ICH guidelines
Inferential statistics
Pharmaceutical company experience
CDISC standards
Leading team collaboration initiatives
Project leadership
Pharmaceutical research
Statistical significance testing
Biostatistical modeling

Full Job Description

The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and support regulatory filings under the supervision of a more senior statistician. This role is responsible for the statistical aspects of study design, study analysis and validation, and study documentation. The Principal Statistician will provide timely and scientifically sound statistical expertise to clinical trials and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. The Principal Statistician will oversee work done by statistics and programming external vendors

Essential Functions

Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
Work collaboratively with members of study teams to meet study and recurring report timelines.
Support the development and implementation of study protocols.
Review and provide input to study-specific data capture systems and participate in their validation.
Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
Write statistical analysis plans, perform data analysis and validation, and interpret analyses.
Support project lead statistician.
Prepare for and attend meetings with regulatory agencies.
Respond to statistical questions from regulatory agencies.
Work closely with statistical programming colleagues.
Monitor CRO guidelines and standards to ensure timeliness and quality of deliverables.
Review and validate CRO deliverables.
Other work as assigned by line manager.
Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents.
Learn drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.
Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities.

Required Knowledge, Skills, and Abilities

Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus.
Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines.
Able to work in a fast-paced, flexible, team-oriented environment.
Possess excellent interpersonal and communication skills (written and verbal).
Strong attention to detail with a view to bring studies to a quality conclusion.
Flexible, positive, creative thinker, good communicator.
Be able to work without close supervision with effective time management.

Required/Preferred Education and Licenses

MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in pharmaceutical or biotechnology industry.
PhD in statistics, mathematics, or a related discipline with a statistical focus and < 2 years of experience in the pharmaceutical or biotechnology industry.
Knowledge of drug development regulations pertinent to statistical analysis.
Bayesian and adaptive design knowledge is preferred.
Proficient SAS & R programming skills, understanding of CDISC models and standards.
Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

#LI-Remote

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $132,000.00 - $198,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.

Apply Now

Refine Your Search

global pharmacovigilance jobs in remote

Principal Statistician, Biostatistics

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Clinician, Companion Animal Clinical Development

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