Pharmacovigilance Specialist
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Job Description
Pharmacovigilance Specialist managing SAE data collection and reporting at Worldwide Clinical Trials. Ensuring regulatory compliance in a dynamic, global environment with a focus on patient safety.
Responsibilities:
- Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements
- 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
Requirements:
- 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
- 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
Benefits:
- Competitive benefits package depending on location
- Pay equity and transparency
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