Sr. PV/Drug Safety Specialist
Location: Cambridge, MA
Experience: Bachelor's Degree and 5 Years
Job Summary: Senior PV/Drug Safety Specialist
The Senior PV Specialist will be responsible for oversight of adverse events and safety data in order to sure the company's compliance with regulatory requirements, contractual requirements and internal procedures.
- The oversight and processing of adverse events that ensures compliance with all regulations and procedures
- The monitoring of vendors and quality to ensure compliance with all regulations and procedures
- Support all day to day activities of all vendors and promptly report or respond to any issues
- Assist in the writing of SOPs or any other special projects that are appointed to you
- Collaborate with vendors and QC for any vendor tasks
- Bachelor's Degree and 3-5 years working with PV and drug safety with a pharmaceutical company
- Experience with clinical trial case processing, Argus safety database, narrative writing, data entry, assessment of reportability, MedDRA and WhoDrug Dictionary coding
- The ability to work independently
Sthree US is acting as an Employment Business in relation to this vacancy.