Pharmacovigilance Specialist - US - Remote
Worldwide Clinical Trials•Durham, NC
•$50,000 - $99,000•Remote
About The Position
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. Serves as Lead PV Associate on small to moderate sized studies that are simple to moderate in complexity and scope of work with support from senior staff.
Requirements
- 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
- Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities
- Ability to anticipate needs and follow through on all assigned tasks
- Bachelor’s degree in a science-related field, nursing, or equivalent
- Minimum of 1 year 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 organization 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
Responsibilities
- 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
Benefits
- Competitive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
