Associate II, Pharmacovigilance - Europe - Home-based

at  Worldwide Clinical Trials

WHO WE ARE

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

WHAT YOU WILL DO

• Author Safety Management Plan for assigned studies. Attend internal and client meetings as appropriate and present at Investigator Meetings
• Review incoming SAE data for completeness and accuracy. Perform QC of SAEs processed by other PV Associates
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
• Generate queries for missing or unclear information and follow-up with sites for resolution. Generate regulatory reports and perform safety submissions as needed. Prepare and submit periodic safety reports as needed

WHAT YOU WILL BRING TO THE ROLE

• Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
• Good understanding of computer technology, and management of relational database systems, including extraction of data
• Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
• Excellent organization skills and ability to handle multiple competing priorities within tight timelines