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)
- 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
- Bachelor’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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