Job 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. 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. Tasks may include but are not limited to: Author Safety Management Plan for assigned studies; Attend internal and client meetings as appropriate; 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; 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; Prepare and submit periodic safety reports as needed; Maintain knowledge and understanding of safety related regulations and guidelines; Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope; May assist with bid defenses or other presentations; May mentor or train new PV staff; Perform other duties as assigned. Other skills and abilities include good understanding of medical and scientific terminology, clinical assessment of adverse drug events, international regulations and reporting requirements; good understanding of computer technology and management of relational database systems; positive attitude and ability to interact diplomatically and professionally; excellent organization skills and ability to handle multiple competing priorities within tight timelines; commitment, dependability, cooperation, adaptability and flexibility; ability to anticipate needs and follow through; ability to receive and provide constructive feedback; ability to work independently and seek input when appropriate; handle confidential and sensitive matters with discretion. Requirements include 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; excellent written and verbal communication skills; excellent organization skills and attention to detail; ability to handle multiple competing priorities while adhering to timelines; ability to work independently and in a matrix team environment; ability and willingness for potential limited travel; fluent in written and verbal English. Promotion to next level based on competency, responsibility, and ability to work independently. The company reserves the right to amend this job description in consultation with the employee to reflect changes in organizational structure or job itself in line with emerging business needs.

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