Senior Drug Safety Associate

South San Francisco  ‐ Onsite
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Description

Senior Drug Safety Associate

A pharmaceutical company in South San Francisco is looking for a Senior Drug Safety Associate to join their team. This is an excellent opportunity to join a stable company with a product on the market and an exciting pipeline. The Senior Drug Safety Associate encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Responsible for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed products, while also assisting management in establishing and implementing departmental strategy. Serves as a liaison to external healthcare providers, investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Science, Clinical Operations, Biometrics, Regulatory & QA, MedSA and Commercial.

Senior Drug Safety Associate Requirements:
  • 3-5 years of Pharmacovigilance / Drug Safety experience or equivalent required.
  • Both pre-approval and post-marketing experience in a global environment highly desired.
  • Oncology experience preferred
  • Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
  • Working knowledge of the overall drug development process
  • Extensive knowledge of medical terminology and principles of clinical assessment of adverse events in the pharmaceutical industry
  • Expertise in MedDRA dictionary with relevance to adverse event coding
  • Extensive experience with software-based drug safety systems required, preferably ARISg
  • Strong computer skills (MS Office)


Education/Training:
  • Bachelor's level degree in life sciences, pharmacy, nursing or equivalent


If you are interested in applying for this role, please respond to this job posting ASAP in order to be considered as we are looking to fill this role immediately.

To find out more about Real please visit www.realstaffing.com
Start date
02/2013
Duration
1 Year
From
Real
Published at
06.02.2013
Project ID:
484560
Contract type
Freelance
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