A leading US biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Drug Safety Public Health Specialist position at their offices in Foster City, CA. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- Safety Specialist, Operations Support team within DSPH Operations
- 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 company 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 post marketing products to ensure accuracy and compliance with company 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.
Skills and Requirements:
- 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.
- Demonstrates 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg on +1 267 405 6995 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.