Valesta is in need of Sr. Clinical Drug Safety Specialist - CA - 2430055 on Sun, 24 Mar 2013 14:01:12 GMT. Title: Sr. Clinical Drug Safety Specialist Company: Biotechnology Industry Location: San Francisco Bay area Key Accountabilities/Core Job Responsibilities: ⢠Use medical background and experience to integrate case-related information including medical conditions, lab results and procedures to write comprehensive SAE case narratives ⢠Generate clinically relevant SAE queries to obtain missing...
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Valesta.
Sr. Clinical Drug Safety Specialist - CA - 2430055
Location: San Francisco California
Description: Valesta is in need of Sr. Clinical Drug Safety Specialist - CA - 2430055 right now, this job will be placed in California. For complete informations about this job opportunity kindly read the description below. Title: Sr. Clinical Drug Safety Specialist
Company: Biotechnology Industry
Location: San Francisco Bay area
Key Accountabilities/Core Job Responsibilities:
- Use medical background and experience to integrate case-related information including medical conditions, lab results and procedures to write comprehensive SAE case narratives
- Generate clinically relevant SAE queries to obtain missing information
- Act as Team Lead for products/studies as applicable
- Represent Clinical Drug Safety as a member of study management teams
- Assist in the oversight of CRO and business partners to ensure adherence to safety management plans and data exchange agreements
- Assist in preparation of safety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, European clinical expert reports)
- Assist in the creation/revision of department procedures and policies
- Assists with Safe! ty Science pharmacovigilance projects as necessary
- Pe! rforms other duties as requested.
- Previous Drug Safety/Pharmacovigilance experience of at least 3-4 years in a global environment.
- At a minimum, Bachelorâs level degree in life sciences, pharmacy, or nursing. RN, PharmD, or MD strongly preferred.
- Familiarity with common Safety databases (e.g., Arisg, AERS, Argus, etc.) necessary.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Valesta.
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This job starts available on: Sun, 24 Mar 2013 14:01:12 GMT
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