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Safety Specialist
Job Code 201803

Job Description:

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

Reports to:  Senior Vice President of Clinical Development

Responsibilities include:

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.

Managing the safety assessments 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 company stakeholders.

Drafting clear and accurate case narratives while adhering to internationally recognized safety categories (including serious and non-serious cases; product quality) in accordance with company conventions and Standard Operating Procedures.

Maintaining an up-to-date understanding case processing conventions and guidelines, company procedures and international drug safety regulations.

Remaining current on the latest adverse event safety profile of each assigned product.

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. 

Participating in the development and management of safety monitoring boards, including development of charters (as needed), coordination of meeting agendas, materials and minutes as well as development, maintenance of trackers to ensure that all safety-related activities are documented and completed in a timely manner, and coordination of requests for safety data 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 skills in organization, presentation, oral and written communications, analysis, and interpersonal relationships with use of strong judgment and tactful discretion as appropriate in 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)

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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:
By fax: 858-646-1154
By mail:
Human Resources
Vical Incorporated
10390 Pacific Center Court
San Diego, CA 92121-4340
P. 858 646 1100 10390 Pacific Center Court, San Diego, California 92121
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