Researcher, Safety Oversight Job at OpenAI (San Francisco)

Manager Environmental Research Safety

Location

United States , Winston Salem

Salary:

51.05 - 76.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor's degree required, Safety Management, Safety Engineering, Occupational Safety & Health, Industrial Hygiene, Environmental Management, Risk Management, Regulatory Compliance or related degree or equivalent experience
5 years of related field experience
Familiarity with regulatory agency code requirements, and the progressive application of these standards, including, “Physical Environment” NFPA 101 Life Safety Code, National Institute of Health, Biosafety in Microbiological and Biomedical Laboratories, EPA, and OSHA requirements for General and Construction Industries preferred
Must have the ability to clearly communicate verbally, in person, and in writing with patients, families/agencies and the health care team
Must possess a strong sense of urgency and make sound decisions
Must be a critical thinker, have ability to solve problems, and is solution oriented
Intermediate to advanced computer skills with demonstration of skill and competence in use of all Microsoft Office applications required
This position requires travel, therefore, will be exposed to weather and road conditions
Operates all equipment necessary to perform the job
Must be able to carry up to 25 pounds of material and various types of equipment

Job Responsibility

Provides leadership oversight for Academic Research Safety, Environmental Compliance, and Physical Environment to ensure regional and institution strategic compliance
Manage Research administration to include, regulatory compliance, Industrial Hygiene, Biosafety, cultivate industry relationships, research ethics, sponsored programs, research coordination and research innovation throughout the region to execute high-priority projects while developing and maintaining exceptional research platform
Manage daily operations of the Research Environmental Health and Safety team
Directs team to implement, coordinate, and present educational opportunities on research safety, select agents, export control, biosafety, infection control, animal research-related environmental and occupation health, emergency management and environmental, safety and health matters
Manage development and implementation of general and specialized research safety programs, audits and surveys to identify, measure, and evaluate known and potential hazards and risks
Coordinates actions among laboratories, departments and facilities to implement corrective actions, as needed
Researches, analyzes and interprets NIH, DoD, NSF, USDA, OSHA, EPA, Homeland Security, and other regulations addressing research safety including zoonosis and environmental, health & safety issues such as hazardous materials & waste, biological and laboratory safety, PPE, etc
Directs and interacts with regulatory agency personnel during compliance inspections for research
Understands and shares technical expertise with others, including leaders, peers, and teammates and utilizes problem solving skills for complex situations that arise
Serves as the technical resource and subject matter expert

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

New

Clin Research Reg Spt Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Fully adheres to applicable safety and/or infection control standards required
Understands and follows data integrity standards and processes required
Ability to effectively manage a higher volume of protocols preferred
Ability to effectively manage moderately complex research protocols/procedures preferred
Possesses a high degree of self-motivation preferred
Recognized ability to function independently preferred
Proficient in managing multiple and competing priorities/demands preferred
Detailed-oriented in record keeping and research documentation preferred

Job Responsibility

Responsible for the coordination and oversight of regulatory requirements of clinical research protocols
Develops increased learned skills, flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols under the direction of the Principal Investigator (PI) and senior leaders
Prepares all regulatory documentation, document filing, tracking, and maintenance
Maintains all logs, including OnCore, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs)
Collects all regulatory documents required to submit to the DWG and PRMC and collates essential regulatory documents within Complion
Prepares/drafts ICF and insert institutional language, ensuring language is consistent with protocol
Enters and loads all required documents to OnCore and Complion
Coordinates and validates the delegation log with the applicable DWG clinical research staff
Prepares and tracks submission to Institutional Review Board (IRB) (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc
Maintains regulatory records and necessary correspondence records

Fulltime

Associate Director, Integrated Pharmacovigilance Operations

Reporting to the Senior Director, Pharmacovigilance Operations, the Associate Di...

Location

United States , Waltham, Massachusetts; San Diego, California

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations
Demonstrated understanding of safety databases, medical literature, and electronic data capture technology
Working knowledge of validated drug safety databases and MedDRA coding dictionary
Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Kailera
Adept at communicating the pharmacovigilance and safety vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate goals
Bachelor’s degree or equivalent in Public Health, Life Sciences, or other relevant fields is required

Job Responsibility

Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements
Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP
Assist with data reconciliation and support safety signal management and aggregate data review activities
Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation
Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities
Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)
Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed
Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection
Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

New

Sr Clinical Research Data Specialist

Works in partnership with the primary point of contact to provide high quality, ...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree Required
2 years of relevant experience Required
or equivalent combination of education and experience Required
Skill in completing assignments accurately and with attention to detail Required
Ability to understand and follow standard research protocols and procedures Required
Ability to process and handle confidential information with discretion Required
Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
Commitment to the University’s core values Required
Ability to work independently and/or in a collaborative environment Required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required

Job Responsibility

Assists in conducting quality checks of data accuracy with data source records as assigned
Perform data entry and verification tasks
Provides custom programming, statistical analysis, reporting and presentation graphics
Prepare and transfer data for analysis
Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics
Adheres to defined application development life-cycle practices
Consults with user departments and sites to assess data preparation and management needs, program design and testing
package selection and use of systems, software and equipment
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately
Answers a broad range of data clarifications for each study

Parttime

New

Clin Research Data Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

23.06 - 32.29 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Skill in completing assignments accurately and with attention to detail required
Ability to understand and follow standard research protocols and procedures required
Ability to process and handle confidential information with discretion required
Commitment to the University’s core values required
Ability to work independently and/or in a collaborative environment required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
Strong interpersonal, communication, and organizational skills required
Highly collaborative, works well in teams required

Job Responsibility

Assumes responsibility for the data management of clinical research protocols
Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed
Formulates and organizes data entry plans to manage assigned caseloads
Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting
Assists in conducting quality checks for data accuracy with data source records as assigned
Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment
Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately
Manages a workload of studies commensurate to level of experience
Answers data clarifications for each study
Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit

Fulltime

New

Clin Research Data Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

23.06 - 32.29 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Skill in completing assignments accurately and with attention to detail required
Ability to understand and follow standard research protocols and procedures required
Ability to process and handle confidential information with discretion required
Commitment to the University’s core values required
Ability to work independently and/or in a collaborative environment required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
Strong interpersonal, communication, and organizational skills required
Highly collaborative, works well in teams required

Job Responsibility

Assumes responsibility for the data management of clinical research protocols
Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed
Formulates and organizes data entry plans to manage assigned caseloads
Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting
Assists in conducting quality checks for data accuracy with data source records as assigned
Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment
Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately
Manages a workload of studies commensurate to level of experience
Answers data clarifications for each study
Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit

Fulltime

Senior Director, Medical Affairs - Clinical Nutrition, Pharmacy Tools and IV Fluids

As the Senior Director Medical Affairs, Clinical Nutrition, Pharmacy Tools and I...

Location

United States , Deerfield

Salary:

252000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree, such as PharmD or PhD required
MD, DO, PA or other clinical specialty considered
Minimum of 10+ years of industry experience, with at least some experience in nutrition ideal
Experience in medical affairs, evidence generation, KOL management, Investigator Initiated Research (IIR) study management, new product development, business development and understanding due diligence
Proven people management/leadership skills with an empathetic style and ability to motivate others
Strong executive presence with excellent leadership, managerial and interpersonal skills and the ability to interact with and influence multiple stakeholders (internal and external) on a variety of levels, to build relationships of credibility and trust with them and to operate effectively in a complex matrix organization
Highly developed business acumen and ability to deal well with ambiguity
Ability to communicate complex scientific/clinical issues in a concise and clear manner
Broad understanding of the regulatory and healthcare environment
Ability to travel 20-25%, including internationally, to attend quarterly meetings, congresses, FDA, etc

Job Responsibility

Leading and guiding a Global Medical Affairs team and establishing and supporting highly functional working relationships with medical and cross-functional partners
Accountable for medical affairs work required to support Clinical Nutrition, IV Fluids and Pharmacy Solutions including thought leadership for business strategy, innovation/new product development, clinical evidence generation strategy and sustaining product activities to ensure successful product approval, launch, and sustenance
Responsible for representing the company with regulatory and legislative agencies related to Clinical Nutrition, IV Fluids and Pharmacy Solutions
Provide expert opinion/due diligence support on business development opportunities
Develop and manage budgets within scope of responsibility
Provide leadership for and partner with HEOR/RWE for clinical evidence generation strategy, scientific and compliance oversight for Evidence Generation such as Investigator Initiated Research and Real World Evidence activities
Support Global Patient Safety as a product and subject matter expert
Development and implementation of the medical strategy, and action plan in alignment with the global business segment for Clinical Nutrition, IV Fluids and Pharmacy Solutions
Act as one of the primary spokespersons for the company with key opinion leaders, at global scientific conferences and advisory boards, and regulatory agencies and accountable to ensure that relevant policies and standards are followed and supported for all aspects of Clinical Nutrition, IV Fluids and Pharmacy Solutions Medical Affairs and work is done with high ethical standards
Accountable for establishing and maintaining strong collaborative relationships with critical colleagues (such as Clinical Research, HEOR/RWE, Global Patient Safety, and Strategy and Delivery) as well as cross-functional partners (such as R&D, RA, Quality and Marketing) to enable a highly efficient and effective working environment

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Researcher, Safety Oversight

OpenAI

Location:
United States , San Francisco

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 21, 2026

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