San Diego, CA
Our client is revolutionizing the bio-pharmaceutical industry and is looking to hire a highly skilled professional for the role of safety specialist in San Diego, CA. This person must be familiar with common safety databases and have clinical knowledge of the infectious disease therapeutic area, patient populations and drug class. The company has one of the strongest reputations in the clinical business to add to your career and resume.
- Performing clear and accurate data capture of cases and be well versed with category of information in accordance with company conventions/guidelines and Standard Operating Procedures.
- Managing the safety assessment of investigational products, including review of individual and aggregate adverse events, preparing safety reports and developing documentation.
- Coordinating the day-to-day review, compilation and delivery of clinical trial safety data.
- Maintaining an excellent knowledge of case processing conventions and guidelines.
- Maintaining a solid working knowledge of the adverse event safety profile of each assigned products and maintaining summary trackers.
- Working knowledge of the latest MedDRA coding convention.
- Maintaining an awareness of global regulatory reporting obligations, especially in the U.S. and E.U. and ensuring compliance with internal and regulatory timelines for adverse event reporting.
- Providing coverage for unexpected AE and SAE handling in accordance with the reporting guidelines established by senior management.
- Assisting in the management of external safety committees/boards.
- Strong organizational, presentation, documentation, analytical, oral/ written, and interpersonal skills with strong judgment and tactful discretion appropriate to a professional setting.
- Clinical knowledge of the infectious disease therapeutic area, patient populations and drug class preferred.
- Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point).
- 3-5 years of experience in clinical safety with a focus on pre-marketing phases. In addition, the ideal candidate will possess a PharmD, RN, or Master of Science Degree and/or have a BS (Health sciences, Biological Sciences) with 5-7 years of working experience in the pharmaceutical/biotech field.