NASDAQ | VICL: 2.66  +0.01
Contact-Us
Contact Us
Country
Location
Division
Job Title
Job Code
Job Type
Date Posted
Closing Date

Summary

vical2clg

Safety Specialist

Job Code 201708

 

Job Description:

Performs all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to the clinical protocol and all related project specific procedures, all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), and all other applicable regulatory guidelines.

Reports to:  Senior Vice President of Clinical Development

Responsibilities include:

  • Managing the safety assessment of investigational products, including review of individual and aggregate adverse events, preparing safety reports and developing documentation that conveys changes in the product risk profile to internal and external stakeholders.
  • Coordinating the day-to-day review, compilation and delivery of clinical trial safety data to the company’s medical monitor for a specific assigned investigational product.
  • Performing clear and accurate data capture of cases and be well versed with category of information (including serious and non-serious cases; product quality) in accordance with company conventions/guidelines and Standard Operating Procedures.
  • Maintaining an excellent knowledge of case processing conventions and guidelines, company’s procedures and international drug safety regulations.
  • Maintaining a solid working knowledge of the adverse event safety profile of each assigned products and maintaining summary trackers.
  • Maintaining a 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.
  • Interacting with Vical Project teams, Clinical Sites, and Medical Experts to identify, resolve or facilitate the resolution of clinical trial safety issues as they arise throughout the project life cycle.
  • 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, ensuring that agendas, materials and minutes are generated in a timely manner for the company’s medical monitor.
  • Participating in the development and management of safety committees/boards, including development of charters (as needed) and ensuring that activities/listings for safety meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/ECs and/or regulatory authorities.
  • Additional duties, as assigned.   

Qualifications and Experience

The successful candidate must have:

  • 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.
  • Familiarity with common safety databases (e.g., Aris, AERS, Argus, SIS etc.) preferred.
  • 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).

Vical's Equal Employment Opportunity Policy

Vical is committed to a policy of equal employment opportunity. In keeping with our policy, Vical will recruit, hire, train and promote into all job titles the most qualified individuals, without regard for race, color, religion, sex, sexual orientation, national origin, ancestry, age, marital status, veteran status, disability, medical condition, usage of family and medical leave, or usage of pregnancy disability leave.



Apply for this position    

HOW TO APPLY

To apply, please reference the specific job code in your cover letter and submit with your C.V. or résumé to Human Resources:

By email: hr@vical.com
By fax: 858-646-1154
By mail:
Human Resources
Vical Incorporated
10390 Pacific Center Court
San Diego, CA 92121-4340
U.S.A.
P. 858 646 1100 10390 Pacific Center Court, San Diego, California 92121
Designed by Mentus
This link to a non-Vical website is provided as a resource. Vical assumes no responsibility for content not provided by Vical, or for practices or standards of any non-Vical websites.