Senior Drug Safety Associate, Pharmcoviligence - US - Remote
What the Senior Drug Safety, Pharmacovigilance does at Worldwide Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. Independently serves as Lead PV Associate on large sized studies/programs that are moderate to complex in scope of work. Serves in a mentorship/leadership role with minimal supervision and guidance. What you will do
- Author Safety Management Plan for assigned studies
- Review incoming SAE data for completeness and accuracy
- 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
- Perform QC of SAEs processed by other PV Associates
- Generate regulatory reports and perform safety submissions as needed
What you will bring to the role
- Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
- Excellent 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 organizational skills and ability to handle multiple competing priorities within tight timelines
Your experience
- Bachelor’s degree in a science-related field, or nursing, or equivalent
- Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials)
- Equivalent combination of relevant education and experience
- Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word).
- Excellent written and verbal communication skills
- Excellent organizational skills and attention to detail
- Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines
- Ability to work independently, prioritize work effectively and work successfully in matrix team environment
- Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting)
- Fluent in written and verbal English
We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.