Drug Safety Associate II

Planet Pharma; Alameda (CA); On-site; USD 54,000 - 68,000; Full time

Job summary

Planet Pharma is seeking a Drug Safety Specialist to provide pharmacovigilance oversight and ensure quality documentation of safety data, especially SAEs, in accordance with global regulations.

The role supports case processing in Argus Safety Database, collaborates with Clinical Development, Regulatory Affairs, and Data Management, and contributes to timely safety reporting. A BS/BA with 5 years' experience or higher degrees with relevant experience is preferred.

Qualifications

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

Responsibilities

• Process and assess SAEs from receipt to case closure in the Argus database.
• MedDRA coding of SAEs and AEs and development/revision of coding conventions.
• Ensure high standard of case quality review with Drug Safety Physician support.

Skills

Biotech knowledge

Regulatory knowledge

Analytical thinking

Time management

Team collaboration

Communication skills

Interpersonal skills

Education

BS/BA degree in related discipline

MS/MA degree in related discipline

PhD in related discipline

BS or MS in Nursing/Pharmacy

Tools

Argus safety database

Job description

Target PR Range: 39-49/hr
*Depending on experience

SUMMARY:

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Technical duties include but are not limited to:

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  • Processing and assessing SAEs from receipt at 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 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 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.
  
  
  
  

SUPERVISORY RESPONSIBILITIES:

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  • None
  
  
  
  

EDUCATION/EXPERIENCE/SKILLS:

Education:

• 
  
  
  
  • 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.
  
  
  
  

Experience:

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  • Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
  
  
  • Clinical trial and spontaneous adverse event processing experience.
  
  
  • Experience using Argus safety database preferred.
  
  
  
  

Knowledge/Skills/Abilities:

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  • 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.
  
  
  
  

JOB COMPLEXITY:

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  • 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
  
  
  
  

*CO/NYC candidates might not be considered