Drug Safety Associate- Hybrid

Job Title:

Drug Safety Associate Hybrid
- Clayton, NC Job Description

The Drug Safety Associate serves as an independent contributor within a global drug safety and pharmacovigilance team, efficiently and effectively completing drug safety tasks and deliverables with minimal oversight. In this role, you obtain and process adverse event data to ensure strict adherence to Good Clinical Practices (GCP), regulatory guidelines, and standard operating procedures, while supporting a collaborative team environment across clinical, scientific, and operational functions.

• Monitor all incoming information to identify potential adverse event (AE) data and ensure timely and accurate processing.
• Assemble relevant adverse event data for team meetings and ongoing safety evaluations.
• Enter adverse event reports into the tracking log, determine whether they are initial, follow-up, or duplicate reports, and create appropriate case folders.
• Review source documents to identify and remove all confidential patient information before further processing.
• Record protocol numbers and site/patient identifiers, when applicable, on all source documents to ensure accurate traceability.
• Provide completed adverse event reports and associated documentation to the designated case owner for further assessment and action.
• Serve as the first reviewer of source documents for adverse event reports within Global Pharmacovigilance, making the initial determination of report completeness.
• Identify the need for follow-up with reporters when information is incomplete or unclear, and initiate or support follow-up activities as appropriate.
• Maintain a basic understanding of clinical study protocols and scope of work to ensure accurate interpretation of adverse event information.
• Maintain a thorough understanding and strict adherence to GCP guidelines and regulatory reporting requirements for adverse events.
• Manage the receipt, review, and filing of literature sources that may contain adverse event information, ensuring that all relevant data are captured and processed.
• Collaborate with Drug Safety Scientists and leadership to foster a strong team environment among drug safety staff and across other departments.
• Demonstrate strong computer literacy and use safety databases, including ARGUS or similar systems, to support efficient case management and documentation.
• Prioritize and organize multiple tasks simultaneously, ensuring that drug safety deliverables are completed accurately and within required timelines.

• Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
• Comprehensive knowledge of medical terminology to accurately interpret and process clinical and safety information.
• Strong interpersonal skills to work effectively with clinical, scientific, and operational stakeholders.
• Excellent organizational and prioritization skills to manage multiple cases and tasks concurrently.
• High degree of flexibility and the ability to multitask in a dynamic, fast-paced environment.
• Strong computer literacy, including proficiency with safety databases and standard office software.
• Ability to work as an independent contributor, efficiently and effectively accomplishing drug safety tasks with minimal oversight.
• 2--3 years of recent experience in a clinical setting or equivalent experience or training.
• Exposure to or experience in clinical drug development, preferably within a pharmacovigilance or drug safety context.

• Associate degree in a relevant scientific, healthcare, or technical discipline.
• Experience with ARGUS or other safety database systems is preferred.
• Basic understanding of clinical study protocols and scopes of work.
• Background in drug safety or pharmacovigilance is highly beneficial.
• Ability to contribute to a collaborative, innovation-driven environment and participate in cross-functional projects.
• Interest in ongoing professional growth through continuous learning and exposure to advanced biopharma and plasma-based technologies.

This position operates in a hybrid work environment, combining remote work with on-site…