Global Safety Officer Jobs

AllSTEM Connections is seeking a Global Safety Officer (GSO) to work on a contract basis, supporting US time zones.

Candidate can be fully remote, open to any US time zone. Must be within US.

12 months with possible extension/contract-to-hire.

JOB SUMMARY

The contract Global Safety Officer (GSO) with work with the Therapeutic Area Head (TAH) to provide safety oversight for assigned products. The contract GSO leads the Safety Analysis Team (SAT) and Global Safety Team (GST) with input from the TAH.

MD REQUIRED

Job Summary

Join us for an exciting safety role in Oncology! The contract Global Safety Officer (GSO) with work with the Therapeutic Area Safety Head (TAH) and lead GSO (where applicable) to provide safety oversight for assigned products. The contract GSO leads and/or contributes to the Safety Analysis Team (SAT) and Global Safety Team (GST) with input from the TAH.

Key Activities

Applicable tasks may vary by product(s) assigned.

Product safety profile, benefit-risk evaluation, and risk communication:

• Participate in product label process
• Identify relevant data and conduct benefit-risk evaluation
• Management Plan [RMP])
• Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS], core Risk

Clinical trial safety

In conjunction with the TAH and lead GSO (where applicable), the contract GSO reviews relevant clinical trial data and study required documents as they pertain to safety.

• Participate in activities related to Data Monitoring Committees (DMCs) and internal data review teams (DRTs)
• Analyze safety data from clinical studies and review clinical study reports as needed
• Develop a strategy as needed for updating safety-related portions of Investigator’s Brochure and Informed Consent Form
• In conjunction with the TAH and lead GSO (where applicable), the contract GSO will develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees

In conjunction with the TAH and lead GSO (where applicable), the contract GSO will provide safety strategy, as well as signal detection, evaluation, and management input for assigned products. This includes working with the TAH and Pharmacovigilance Scientists (PVS) to:

• Documents work as required in the safety information management system
• Decide on need for further actions on safety issues and in conjunction with the TAH and assigned PVSs lead a cross-functional discussion
• Prepares and presents recommendations on safety issues to the Global Safety Team and escalates, and in conjunction with the TAH and PVS present the data to the executive level cross-functional decision-making body
• Create safety assessment reports
• May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Evaluate safety signal detection findings validate signals and determine a need and develop a strategy for further analysis
• Develop signal detection strategy

Risk management and minimization activities

• Develop materials for additional risk minimization measures as applicable to role
• Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document

Periodic (aggregate) safety reporting

• New drug applications and other regulatory filings
• Review and approve filing documents relevant to drug safety
• Review and assist in development of Pediatric Investigation Plan (PIP)
• Review and approve periodic safety reports
• Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER, DSUR)
• Develop a strategy for and lead preparation of response to regulatory agency inquiries on safety topics related to regulatory filings
• Prepare for and attend health authority meetings involving patient safety issues

Safety Governance Leadership

• Participates in safety governance meetings per Standard Operating Procedures and Manuals in conjunction with the TAH and assigned PVS

Commercialization process

• Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams

EDUCATION & EXPERIENCE

• MD or DO is a hard requirement. US Board-certified ideal, board-qualified OK.
• 5 or more years of experience in pharmacovigilance.
• 2 or more years of Clinical experience

KNOWLEDGE AND SKILLS

• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
• Processes and regulations for pharmacovigilance and risk management
• Pharmaceutical experience in immune oncology
• Safety data capture in clinical development and post-market settings
• MedDRA and other dictionaries used in pharmacovigilance
• Methods of qualitative and quantitative safety data analysis
• Internal organizational and governance structure
• Safety database structure and conventions
• General medicine, epidemiology, physiology, and pharmacology
• Product and disease state knowledge
• Advanced understanding of interfaces across various pharmacovigilance and risk management processes
• Drug development and lifecycle management

PHARMACOVIGILANCE SKILLS

• Data interpretation and synthesis
• Good clinical and scientific judgment
• Advanced skills in application of statistical and epidemiological methods to pharmacovigilance
• Signal detection and evaluation
• Application of medical concepts and terminology
• Ability to convey complex, scientific data in an understandable way
• Document writing and source document review
• Basic skills in application of statistical and epidemiological methods to pharmacovigilance
• Aggregate data analysis
• Ability to analyze and interpret complex safety data