Drug Safety Coordinator

Connect Life Sciences; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Connect Life Sciences seeks a Drug Safety specialist to provide expertise and ensure quality documentation of safety data, especially serious adverse events. You will manage case processing in Argus Safety, including intake, narrative writing, MedDRA coding, and expedited reporting, while ensuring regulatory compliance across clinical and post-marketing safety activities.

You will coordinate with Clinical Development, Regulatory Affairs, Data Management, and Project Management to maintain high

Qualifications

• BS/BA degree in related discipline; 5 years of related industry experience.
• MS/MA degree in related discipline; 3 years of related experience.
• PhD in related discipline.
• BS or MS in Nursing, Pharmacy or other clinical degree with 3–5 years clinical experience.

Responsibilities

• Process and assess SAEs from receipt to case closure in the Argus database.
• MedDRA coding of SAEs and AEs; develop conventions for consistent data.
• Define high-standard case quality review with Drug Safety Physician support.
• Schedule submissions of expedited safety reports in ARGUS as needed.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.

Skills

Argus experience

Pharmacovigilance

Case processing

MedDRA coding

Quality review

Expedited reporting

Education

BS/BA in related field

MS/MA in related field

PhD in related field

Nursing/Pharmacy degree

Tools

Argus Safety

Job description

This role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs). This role provides support for all major tasks related to the management and best utilization of case processing in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Drug Safety department procedures in all aspects of drug safety case processing and reporting.

Responsibilities

• Processing and assessing SAEs from receipt at Exelixis to case closure in the Argus database, including query generation, narrative and ASE writing.
• MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of Exelixis MedDRA Coding Conventions to ensure consistent data categorization.
• Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician.
• Scheduling submissions of expedited safety reports in ARGUS as needed.
• Collaborating with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data.
• Additional duties and responsibilities as required.
• None (Supervisory responsibilities).
• Capable of following predefined procedures for specific tasks.
• Capable of identifying task-related challenges and prioritizing activity accordingly.
• Seeks help if task-related challenges are identified and implements proposed solutions.

Qualifications

• BS/BA degree in related discipline and 5 years of related industry experience; or,
• MS/MA degree in related discipline and 3 years of related experience; or,
• PhD in related discipline; or;
• BS or MS in Nursing, Pharmacy or other clinical degree with a minimum of 3-5 years of clinical experience.

Required Skills

• Minimum 3 years of recent hands-on Argus experience, including end-to-end pharmacovigilance case processing, case management, and quality review.
• Strong end-to-end pharmacovigilance case processing experience, including intake, assessment, MedDRA coding, narrative writing, follow-up activities, expedited reporting, and quality control (QC) review to ensure complete, accurate, and compliant safety case documentation for both clinical and post-marketing cases.
• Minimum 5 years of pharmacovigilance experience within a biotech, pharmaceutical, or CRO environment.
• Clinical trial and spontaneous adverse event processing experience.
• Knowledge of biotechnology/pharmaceutical sector.
• Knowledge of regulatory framework governing patient safety.
• Adopts an analytical approach to solve problems relevant to the role.
• Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work.
• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
• Provides verbal and written communications that are clear and easy to understand. Keeps management informed of potential issues in a timely manner.
• Works collaboratively with team members.
• Good interpersonal skills and understanding of differing views.
• Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers.
• Develops and maintains knowledge of products, tools and data sources relevant to the role.

Preferred Skills

• CRO pharmacovigilance experience.
• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
• Experience using Argus safety database preferred.