Associate Manager/Specialist, Risk Management
- Tarrytown, NY
What you'll be doing
- Assume lead role in conducting safety database queries and review and tabulation of query output for: SMT meetings, signal management activities, preparation of regulatory documents, regulatory agency and other ad hoc queries. Participate in tracking and documentation of signal management activities. Actively participate in the development and maintenance of relevant SOPs and supporting documents. Actively participate in process improvement activities within PVRM. Regularly interacts with personnel external to PVRM on matters concerning specific compounds or problems. Participate in drafting test for query responses and regulatory documents. Perform other duties as assigned by management if required.
What your background should be
- Typically with 6-8 years of relevant experience in industry/academia including at least 1-2 years of risk management experience in pharmaceutical/biotech industry. Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing activities for both clinical trial and post-marketing environments. Skilled in querying PVRM safety system database. Ability to write clear and accurate responses summarizing safety data and risk management activities.
Required Schooling / Training
- BS/MS preferred.
Who is the client company
- This is a biotechnology company.
- If you are interested in this position, send your resume to email@example.com