[Hiring] Senior Drug Safety Associate @Worldwide Clinical Trials

Role Description

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

Qualifications

• 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

Benefits

• Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law