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

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