job specification

What the Associate II, 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. Serves as Lead PV Associate on moderate to large sized studies that are moderate to complex in scope of work with moderate support from senior staff.

What you will do

• Author Safety Management Plan for assigned studies
• Attend and present at Investigator Meetings
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
• 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

• Strong understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
• Strong understanding of computer technology, and management of relational database systems, including extraction of data
• Excellent organizational 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

Your experience

• Minimum of 3 years of pharmacovigilance experience (pre-approval clinical trials)
• Bachelor’s degree in science related field, nursing or 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