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Drug Safety Public Health Specialist
Ref No.: 17-08682
Position Type:Contract
Start Date: 10/12/2017
Specialist (Contract), Drug Safety & Public Health (DSPH) – Training and QC
Specific Responsibilities:

§ Safety Specialist, Operations Support team within DSPH Operations
Essential Duties and Job Functions:

§ Establishes work priorities and direction with input from Manager.
§ Provides new hire (onboarding) Argus training within DSPH and CROs as required.
§ Assists in development and maintenance of Ops Support training materials as required.
§ Provides training to DSPH Operations personnel on Gilead data entry conventions as required.
§ Assists with other Operations Support training activities as required.
§ Performs quality control (QC) checks for data entered for ICSR reports from both investigational and postmarketing products to ensure accuracy and compliance with Gilead conventions and regulatory standards.
§ Provides feedback on results of QC check to DSPH Operations Case Owners and Managers.
§ Collates findings from QC checks.
§ Seeks assistance from appropriate internal and external resources.
§ Will interact with other DSPH functional areas to QC ICSRs efficiently and accurately.
§ Identifies issues/concerns in a timely and appropriate manner and communicates these to Manager.
§ Remains current with case handling SOPs, WRKs, manuals and database technology.
§ Organizes individual workload to ensure compliance with PVA and other global regulatory reporting requirements.
§ Ensures departmental workflow processes and timelines are followed.
§ Understands DSPH Business Continuity processes, as applicable.
Knowledge, Experience and Skills:

§ Excellent interpersonal and communication skills, both written and oral.
§ Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
§ Safety database, data entry and QC experience preferred.
§ Training experience preferred but not required.
§ Understanding of medical terminology and the ability to summarize medical information required.
§ The ability to assess data and understand the medical/safety implications.
§ Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred.
§ Demontrates initiative, teamwork and accountability.
§ Demonstrated success working both independently and in collaboration with others.
§ A quality driven individual with strong attention to detail and accuracy is required.
§ Strong organizational skills, and ability to adapt to change.
§ A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required.
§ Ability to follow guidelines and procedural documents.
§ Case processing experience is required.
§ 2+ years of drug safety experience and a BS degree in a life sciences field
§ 3+ years of experience in the drug safety field and an AA degree.
§ Experience in both clinical and post-marketing environment preferred.

Intake Call Notes:
The perfect candidate need to be available until 5pm and will be in house Position is a training role, must have QC exp, PowerPoint, Excel, Word as well as Database exp. There will be onsite interviews only HM willing to accept more junior candidates