Opportunity of Drug Safety Associate/Pharmacovigilance (Stamford CT), USA

Opportunity of Drug Safety Associate/Pharmacovigilance (Stamford CT), USA
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Opportunity of Drug Safety Associate/Pharmacovigilance (Stamford CT)

About the job

Job Title: Drug Safety Associate

Location: Stamford CT

Duration: 12 Months (Possibility of extension)

Job Summary

Primary Responsibilities

 

  • Establishes and maintains departmental procedures; oversees training and continuous improvement.
  • Support DSP in pharmacovigilance activities including: signal detection and tracking activities, literature surveillance, oversight of medical review performed by outsourced vendor
  • Collaborate with DSP safety physicians with PV activities as assigned
  • Writing safety analysis reports
  • Oversight of medical review and aggregate report activities performed by outsourced vendors
  • Support clinical project teams for investigational products; provide project teams providing expertise in PV activities
  • Collaborate with Clinical Research and Development, medical Affairs, Regulatory Affairs
  • Provide Leadership in the development, implementation, and maintenance of robust procedures for PV activities within the DSP department
  • Participate on the Safety Evaluation Group with local and global drug safety colleagues to monitor and discuss safety signal evaluation topics
  • Contribute to the writing and compilation of PADERs, Annual reports and PSURs/PBRER.
  • Author and review department SOPs as needed.
  • Participate in Regulatory Inspections, external audits and investigator meetings

Education And Experience Requirements

 

  • Bachelorโ€™s degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
  • Minimum 10 years of experience in a pharmaceutical/biopharmaceutical company
  • Minimum 7 years of Drug Safety experience

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