Neo tech solutions Hiring for Drug Safety Associates at Remote Full Time

Drug Safety Associates

Remote

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 at the Company 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 the Company 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.

Job Type: Contract

Pay: $45.00 – $50.00 per hour

Schedule:

• 8 hour shift

Work Location: Remote

Speak with the employer
+91 09086984351