Drug Safety Specialist

Akkodis; Alameda (CA); On-site; USD 114,616,000 - 143,270,000; Full time

Job summary

Akkodis is seeking a Drug Safety Associate II for a 6-month contract in Alameda, CA. This role focuses on safety data quality and SAE case processing in Argus, supporting regulatory compliance and pharmacovigilance.

You will work with cross-functional teams to ensure timely safety reporting, MedDRA coding, and documentation accuracy, leveraging your biotech/pharma experience and attention to detail.

Qualifications

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

Responsibilities

• Process and assess SAEs from receipt to case closure in the Argus database with narrative writing.
• MedDRA coding of SAEs and AEs and development of coding conventions.
• Maintain high-quality safety data documentation in coordination with the Drug Safety Physician.
• Schedule submissions of expedited safety reports in ARGUS as needed.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.

Skills

SAE processing

MedDRA coding

Safety data management

Regulatory knowledge

Cross-functional collaboration

Time management

Written/verbal communication

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

BS/MS in Nursing/Pharmacy or clinical degree

Tools

Argus safety database

Job description

Akkodis is seeking a Drug Safety Associate II role is 6 months contract role with a client located in Alameda, CA.

Pay Range: $40-$50/hr; The rate may be negotiable based on experience, education, geographic location, and other factors.

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:

• Processing and assessing SAEs from receipt 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.

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:

• 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:

• 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.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.

In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

Fair Chance Equitable Employment

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers